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SYNTHES MONUMENT 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
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| Catalog Number 04.402.009S |
| Device Problem
Unintended Movement (3026)
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| Patient Problems
Failure of Implant (1924); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Joint Disorder (2373); Limited Mobility Of The Implanted Joint (2671)
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).Date of postoperative radial stem loosening and pain development is unknown.(b)(4).Complainant device is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested and is currently pending completion.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that a patient suffered a fall and fractured his right elbow on (b)(6) 2016.The patient underwent a surgery to repair the right radial head fracture, coronoid fracture by utilizing a radial head replacement and right collateral ligament repair on (b)(6) 2016.Subsequently, the radial stem loosened postoperatively, presumably at the stem bone interface.Patient experienced limited range of motion and forearm and wrist pain.The patient underwent revision surgery on (b)(6) 2017 where the loose radial head component was removed from the right elbow, and a contracture release of the right elbow was performed.The patient was revised to radial head arthroplasty with modular component.Concomitant devices reported: 24mm cocr radial head (part# 09.402.024s, lot# 7855839, quantity 1).This report is for one (1) 9mm ti straight radial stem 30mm-sterile.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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Expiration date.Udi# (b)(4).Device history records review was completed for part# 04.402.009s, lot# h081285.Manufacturing location: (b)(4), manufacturing date: apr 19, 2016, expiry date: mar 31, 2021.Raw material part 21014 lot 7777885 was reviewed.Raw material was received from nf & m international.Certificate of report for titanium received from nf & m meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet ¿ incoming final inspection meets inspection acceptance criteria.Certificate of compliance received from avalign meet specification.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.(b)(6) 2016: patient fell off his truck (b)(6) 2017: revision surgery with forearm/wrist contracture release, hardware removal of synthese radial head and stem, was determined device was loose, patient revised to competitors (wright) radial head system (b)(6) 2017: post-revision x-ray taken; unavailable, confirmed placement is fine (competitor¿s device) (b)(6) 2017: post-revision office visit; reports of numbness/tingling (b)(6) 2017: post-revision office visit, electrodiagnostic nerve study conducted, patient reports of pain and limited range of motion, determined there was nerve damage.(b)(6) 2017: office visit, reports of patient pain, slight radial neuropathy and numbness in fingertips a device history record review was performed for the subject device: manufacturing location: supplier démodé, packaged by monument manufacturing date: (b)(6) 2016 expiration date: (b)(6) 2021 part #: 04.402.009s, lot#: h081285 (sterile) - 9 mm ti straight radial stem 30mm-sterile.Quantity 25.Raw material part 21014 lot 7777885 was reviewed.Raw material was received from nf & m international.Certificate of report for titanium received from nf & m meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet ¿ incoming final inspection - meets inspection acceptance criteria.Certificate of compliance received from avalign meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterigenics (corona).¿sterility documentation was reviewed and determined to be conforming.¿ an investigation was performed for the subject device: complaint description: it was reported that a patient underwent surgery to repair a fractured right elbow utilizing a radial head replacement on (b)(6) 2016.Subsequently, the radial stem loosened.The patient underwent revision surgery on (b)(6) 2017.Product was not returned.Photos were provided of the device.However, the photos do not show evidence of the reported condition of post-operative loosening.This complaint was unable to be confirmed.Whether this complaint can be replicated at customer quality (cq) via functional test is not applicable for this complaint condition.The complaint device was manufactured in april 2016.Manufacturing location: supplier nemcomed, packaged by monument manufacturing date: (b)(6) 2016 expiration date: (b)(6) 2021 part #: 04.402.009s, lot#: h081285 (sterile) - 9 mm ti straight radial stem 30mm-sterile.Quantity 25.Raw material part 21014 lot 7777885 was reviewed.Raw material was received from nf & m international.Certificate of report for titanium received from nf & m meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet ¿ incoming final inspection - meets inspection acceptance criteria.Certificate of compliance received from avalign meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterigenics (corona).¿sterility documentation was reviewed and determined to be conforming.¿ the material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.A dimensional inspection of the complaint device was unable to be performed at cq because the device was not returned for investigation.Appropriate actions have been initiated/taken to address the matter.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on (b)(6) 2017, the patient underwent a revision of radial head prosthesis due to stem loosening and disassociation of head from the stem, and replaced with a wright modular component.On (b)(6) 2016, the patient sustained injury to his right elbow due to fall.The patient was experiencing severe pain and had swelling.X-ray result revealed fracture of the distal right humerus (trochlea), displaced fracture of the radial head, minimally displaced fracture of the ulna (coronoid fracture), soft tissue swelling and small joint effusion.Ct revealed complex fracture around the elbow with fractures of the ulna, radius and fractures of both the capitellum and the trochlea of the distal humerus, and a small amount of air was seen in the joint space with no soft tissue break.On (b)(6) 2016, the patient underwent an open reduction and internal fixation of the right coronoid fracture type ii, a right radial head replacement and a right collateral ligament repair and was implanted with a depuy synthes radial head prosthesis.After the surgery, the patient continued to suffer pain and inability to regain functional use of the right arm and right elbow, and developed a right forearm contracture and nervous system dysfunction.On (b)(6) 2016, the surgeon reviewed the fluoro images and it appeared that the stem was loose and two (2) anchors were present.X-ray result showed disassociation between the radial head and the stem.On or about (b)(6) 2016, the patient was complaining of increased pain in the right shoulder, upper arm and elbow.On (b)(6) 2017, the patient continued to suffer pain and dysfunction in the right upper extremity and right hand.On (b)(6) 2017, the patient sought a second opinion.Based on the history taken by the surgeon, the patient was suffering from constant pain, decreased range of motion and that the hand felt locked.The surgeon reviewed the x-ray result and stated that the medical aspect of the osteotomized radial head was uncovered by the implant, which overhangs laterally with the arm in supination.The patient also had some forearm and wrist discomfort, which likely did contribute to the loss of forearm rotation.On (b)(6) 2017, another surgeon reviewed the result of the x-ray, which was taken on (b)(6) 2017, and stated that the x-ray revealed an eccentrically placed radial head prosthesis.This report is for an radial stem.This is report 2 of 2 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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On (b)(6) 2019, an electrodiagnostic was conducted and revealed evidence of moderate right sensory motor demyelinating ulnar neuropathy at the elbow.On (b)(6) 2019, the patient underwent a right elbow subcutaneous ulnar nerve transportation due to a confirmed carpal and cubital tunnel syndromes and failure of conservative treatment.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Updated event description: it was reported that on (b)(6) 2017, the patient underwent a revision of radial head prosthesis due to stem loosening and disassociation of head from the stem, and replaced with a wright modular component.On (b)(6) 2016, the patient sustained injury to his right elbow due to fall.The patient was experiencing severe pain and had swelling.X-ray result revealed fracture of the distal right humerus (trochlea), displaced fracture of the radial head, minimally displaced fracture of the ulna (coronoid fracture), soft tissue swelling and small joint effusion.Ct revealed complex fracture around the elbow with fractures of the ulna, radius and fractures of both the capitellum and the trochlea of the distal humerus, and a small amount of air was seen in the joint space with no soft tissue break.On (b)(6) 2016 the patient underwent a cardiac catherization due to abnormal stress test result, had tid and inferior ischemia prior to the surgical repair of the right hand.On (b)(6) 2016, the patient underwent an open reduction and internal fixation of the right coronoid fracture type ii, a right radial head replacement and a right collateral ligament repair and was implanted with a depuy synthes radial head prosthesis.After the surgery, the patient continued to suffer pain and inability to regain functional use of the right arm and right elbow, and developed a right forearm contracture and nervous system dysfunction.On (b)(6) 2016, the surgeon reviewed the fluoro images and it appeared that the stem was loose and two (2) anchors were present.X-ray result showed disassociation between the radial head and the stem.On or about (b)(6) 2016, the patient was complaining of increased pain in the right shoulder, upper arm and elbow.On (b)(6) 2017, the patient continued to suffer pain and dysfunction in the right upper extremity and right hand.On (b)(6) 2017, the patient sought a second opinion.Based on the history taken by the surgeon, the patient was suffering from constant pain, decreased range of motion and that the hand felt locked.The surgeon reviewed the x-ray result and stated that the medical aspect of the osteotomized radial head was uncovered by the implant, which overhangs laterally with the arm in supination.The patient also had some forearm and wrist discomfort, which likely did contribute to the loss of forearm rotation.Additionally, on (b)(6) 2017, the patient underwent a removal of loose radial head component, radial head arthroplasty with modular component and rotational contracture release.On(b)(6) 2017, another surgeon reviewed the result of the x-ray, which was taken on (b)(6) 2017, and stated that the x-ray revealed an eccentrically placed radial head prosthesis.On (b)(6) 2017, the patient was diagnosed with acute left-sided low back pain with left-sided sciatica where there is a sudden onset left low back pain with radiation to posterior left leg and thigh, no trauma and not improving with chiropractic treatment.On (b)(6) 2019, the patient was diagnosed to have paresthesia of the right leg.Varicose veins of right lower extremity with pain is present.On (b)(6) 2019, an electrodiagnostic was conducted and revealed evidence of moderate right sensory motor demyelinating ulnar neuropathy at the elbow.On(b)(6) 2019, the patient underwent a right elbow subcutaneous ulnar nerve transportation due to a confirmed carpal and cubital tunnel syndromes and failure of conservative treatment.
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Manufacturer Narrative
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Product complaint #(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Complaint description: it was reported that a patient underwent surgery to repair a fractured right elbow utilizing a radial head replacement on (b)(6) 2016.Subsequently, the radial stem loosened.The patient underwent revision surgery on (b)(6) 2017.The device was not returned.A radial stem and radial head were present in the photograph, however there was no evidence of the reported condition of post operative loosening.A depuy synthes etched logo was visible on the radial head, however, no other device identification was visible.This complaint was unable to be confirmed.A functional test, dimensional inspection, and drawing review was not completed as the devices were not returned.The radial head prosthesis system (rhp system) was recalled and relevant actions have been taken to address the issue.Since the radial head prosthesis system has been recalled and the complaint condition will be investigated through those efforts, no further investigation is required.Based on the investigation findings, it has been determined that no further corrective and/or preventative action is proposed.Complaint description: it was reported that a patient underwent surgery to repair a fractured right elbow utilizing a radial head replacement on may 17, 2016.Subsequently, the radial stem loosened.The patient underwent revision surgery on february 24, 2017.Product was not returned.Photos were provided of the device.However the photos do not show evidence of the reported condition of post operative loosening.This complaint was unable to be confirmed.Whether this complaint can be replicated at customer quality (cq) via functional test is not applicable for this complaint condition.The complaint device was manufactured in april 2016.Manufacturing location: supplier nemcomed, packaged by monument, manufacturing date: 19-apr-2016, expiration date: 31-mar-2021, part #: 04.402.009s, lot#: h081285 (sterile) - 9 mm ti straight radial stem 30mm-sterile.Quantity (b)(4).Raw material part 21014 lot 7777885 was reviewed.Raw material was received from nf & m international.Certificate of report for titanium received from nf & m meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet ¿ incoming final inspection - meets inspection acceptance criteria.Certificate of compliance received from avalign meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Scn 12446 sterigenics (corona).¿sterility documentation was reviewed and determined to be conforming.¿ the material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.A dimensional inspection of the complaint device was unable to be performed at cq because the device was not returned for investigation.The radial head prosthesis system (rhp system) was recalled and relevant actions have been taken to address the issue.Since the radial head prosthesis system has been recalled and the complaint condition will be investigated through those efforts, no further investigation is required.A drawing review was not performed during this investigation due to aforementioned.Based on the investigation findings, it has been determined that no further corrective and/or preventative action is proposed.Device history lot manufacturing location: supplier nemcomed, packaged by monument manufacturing date: 19-apr-2016.Expiration date: 31-mar-2021.Part #: 04.402.009s, lot#: h081285 (sterile) - 9 mm ti straight radial stem 30mm-sterile.Quantity (b)(4).Raw material part 21014 lot 7777885 was reviewed.Raw material was received from nf & m international.Certificate of report for titanium received from nf & m meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet ¿ incoming final inspection -meets inspection acceptance criteria.Certificate of compliance received from avalign meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Scn 12446 sterigenics (corona).¿sterility documentation was reviewed and determined to be conforming.¿ device history batch null, device history review no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: updated investigation with receipt of photograph: the device was not returned.A photograph was reviewed.A radial stem and radial head were present in the photograph, however there was no evidence of the reported condition of post operative loosening.A depuy synthes etched logo was visible on the radial head, however, no other device identification was visible.This complaint was unable to be confirmed.A functional test, dimensional inspection, and drawing review was not completed as the devices were not returned.Relevant actions have been taken to address the issue.Based on the investigation findings, it has been determined that no further corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Updated data-b6, b7.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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