MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Model Number 09.402.022S

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is the patient.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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.

Event Description

It was reported on (b)(6) 2016 the patient underwent surgery to repair his radial-head fracture.During the surgery, the surgeon repaired the patient's radial head fracture by replacing it with a synthes radial head prosthesis.The patient participated in regular post-op physical therapy and occupational therapy.On (b)(6) 2016, a patient fell from a ladder at work and broke the radial head of his left arm.On (b)(6) 2018, the patient was informed by the surgeon that his implant is failing.X-rays showed loosening of the radial head prosthesis with presumed significant osteolysis around the radial head implant.More likely than not the depuy synthes radial head and stem will require surgical removal from the patient's left arm and possibly additional future "salvage" surgeries.Due to a failed and defective radial head prosthesis system the patient has suffered and continues to suffer bodily injury, pain and suffering, disability, disfigurement, mental anguish, and loss of enjoyment of life.As a direct and proximate result of the failed and defective radial head prosthesis system, the patient will more likely that not need to undergo a premature revision surgery of his prosthetic radial head, causing further permanent impairment and weakness in his ligaments, bone and muscles and potentially more surgeries in the future.This report is for one (1) 22mm cocr radial head standard height/12.5mm-sterile.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

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.Manufacturing location: supplier - avalign nemcomed / inspected, packaged and released by: monument.Release to warehouse date: 15-aug-2016.Expiration date: 31-jul-2021.Part number: 09.402.022s, 22mm cocr radial head standard height/12.5mm ¿ sterile.Lot number: h063656 (sterile).Lot quantity: 25.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign dated 29-jul-2016 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 12868 supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 21022, tialnbri8.00.Lot number: 5345317.Lot quantity: (b)(4).Product traveler met all inspection acceptance criteria.Raw material inspection sheet met all inspection acceptance criteria.Certified test report supplied by perryman company dated 18-sep-2006 and inspection certificate supplied by vsmpo dated 10-apr-2006 were reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Part number: 41060, cocrmori25.40.Lot number: 9821576.Lot quantity: (b)(4).Certificate of tests supplied by carpenter dated 13-may-2015 was reviewed and determined to be conforming.Lot summary report dated 27-may-2015 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release 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.

Manufacturer Narrative

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.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Manufacturing location: supplier - (b)(4) , packaged and released by: monument release to warehouse date: aug 15, 2016, expiration date: jul 31, 2021, part number: 09.402.022s, 22mm cocr radial head standard height/12.5mm ¿ sterile, lot number: h063656 (sterile) , lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign dated 29-jul-2016 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, ns051180 rev c met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev c was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 12868 supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 21022, tialnbri8.00, lot number: 5345317, lot quantity: 4,257 lbs.Product traveler met all inspection acceptance criteria.Raw material inspection sheet, rmtialnbri8_00 rev j met all inspection acceptance criteria.Certified test report supplied by perryman company dated 18-sep-2006 and inspection certificate supplied by vsmpo dated 10-apr-2006 were reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Part number: 41060, cocrmori25.40, lot number: 9821576, lot quantity: 2,180 lbs.Certificate of tests supplied by carpenter dated may 13, 2015 was reviewed and determined to be conforming.Lot summary report dated 27-may-2015 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review: nov 07, 2019: dhr reviewed.This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release 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.

Event Description

Updated event description: it was reported that on (b)(6) 2016, the patient underwent open reduction internal fixation of his right radial head.On (b)(6) 2016, a patient fell about six feet off a ladder and sustained bilateral elbow fracture dislocations of both elbows.Closed reduction of fracture dislocations on the same day in the emergency department was performed.On (b)(6) 2016, the patient underwent left elbow fracture dislocation radial head replacement, and lateral collateral ligament repair and long arm cast.Right elbow fracture dislocation long arm cast by replacing it with a synthes radial head prosthesis.On (b)(6) 2016, the patient underwent closed reduction of right elbow fracture-dislocation with a splinting due to right elbow fracture dislocation.On (b)(6) 2018, the patient was informed by the surgeon that his implant is failing.X-rays showed loosening of the radial head prosthesis with presumed significant osteolysis around the radial head implant.More likely than not the depuy synthes radial head and stem will require surgical removal from the patient's left arm and possibly additional future "salvage" surgeries.Due to a failed and defective radial head prosthesis system, the patient has suffered and continues to suffer bodily injury, pain and suffering, disability, disfigurement, mental anguish, and loss of enjoyment of life.As a direct and proximate result of the failed and defective radial head prosthesis system, the patient will more likely that not need to undergo a premature revision surgery of his prosthetic radial head, causing further permanent impairment and weakness in his ligaments, bone and muscles and potentially more surgeries in the future.This complaint involves two (2) devices.

Manufacturer Narrative

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.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) were reviewed and it was noticed that there was a significant amount of bone degradation(osteolysis) around the implant but there are no issues of stem or radial head loosening.The complaint condition could not be confirmed from the provided images.However, there are known issues with the radial head implants that are captured in capa.There is also a recall (recall# 555531) that was initiated as part of field action investigation hhe-2016-180.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.However, based on previous complaints, the radial head prosthesis system (rhp system) was recalled under recall# 555531.Any related investigations and assessment of the risks associated with this system will be covered under recall# 555531 and hhe-2016-180 investigations.Since the radial head prosthesis system has been recalled and the complaint condition was investigated through those efforts, no further investigation is required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A corrective and/or preventative action is proposed or already launched.See related actions 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.

Manufacturer Narrative

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.

Event Description

It was reported that on (b)(6) 2016, the patient underwent open reduction internal fixation of his right radial head.On (b)(6) 2016, a patient fell about six feet off a ladder and sustained bilateral elbow fracture dislocations of both elbows.Closed reduction of fracture dislocations on the same day in the emergency department was performed.On (b)(6) 2016, the patient underwent left elbow fracture dislocation radial head replacement, and lateral collateral ligament repair and long arm cast.Right elbow fracture dislocation long arm cast by replacing it with a synthes radial head prosthesis.On (b)(6) 2016, the patient underwent closed reduction of right elbow fracture-dislocation with a splinting due to right elbow fracture dislocation.On (b)(6) 2018, the patient was informed by the surgeon that his implant is failing.X-rays showed loosening of the radial head prosthesis with presumed significant osteolysis around the radial head implant.More likely than not the depuy synthes radial head and stem will require surgical removal from the patient's left arm and possibly additional future "salvage" surgeries.Due to a failed and defective radial head prosthesis system, the patient has suffered and continues to suffer bodily injury, pain and suffering, disability, disfigurement, mental anguish, and loss of enjoyment of life.As a direct and proximate result of the failed and defective radial head prosthesis system, the patient will more likely that not need to undergo a premature revision surgery of his prosthetic radial head, causing further permanent impairment and weakness in his ligaments, bone and muscles and potentially more surgeries in the future.On (b)(6) 2018, the patient presented left elbow has partial nonunion; continues with pain and a 20 -pound lifting restriction.On (b)(6) 2018, the patient had osteoarthritis with bilateral knee pain and joint effusions.Right knee prepatellar bursitis w / effusion.Hypertension, elevated cholesterol, anxiety and depression also was noted.On (b)(6) 2019, the patient still had osteoarthritis / bilateral knee pain / joint effusions, hypertension, and work-related fractured elbows w / chronic elbow pain.

Manufacturer Narrative

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.

• Brand Name: 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9311856
• MDR Text Key: 183707286
• Report Number: 2939274-2019-62126
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982132598
• UDI-Public: (01)10886982132598
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 09.402.022S
• Device Catalogue Number: 09.402.022S
• Device Lot Number: H063656
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: 8MM TI STRAIGHT RADIAL STEM 28MM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR