MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.007S

Device Problem Device Slipped (1584)

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

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown radial stem prosthesis/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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 that on (b)(6) 2018, the patient underwent a revision using a non-synthes radial head prosthesis system.During the surgery, the physician(s) inspected the synthes radial head prosthesis system and determined that it had in fact loosened and was entirely unstable.There was a significant bone loss requiring a complete left elbow revision.Initially, the patient underwent surgery to repair a radial head fracture in the left arm on or about (b)(6) 2015 and was implanted with a synthes radial head prosthesis system.On or about (b)(6) 2018, the patient¿s physicians determined that the implanted synthes radial head prosthesis had loosened at the stem bone interface and recommended a revision surgery.This report is for an unknown radial stem prosthesis.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.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

Subsequent to the surgery, the patient suffered nerve injury, loss of sensory and motor control, arthritic issues, permanent strength and control loss, and other related complications.On (b)(6) 2015, the patient fell at work and found to have ulno-humeral subluxation and radial head fracture and was placed into a splint.Complains of pain in the left elbow with numbness.On or about (b)(6) 2018, the patient¿s physicians determined that the implanted synthes radial head prosthesis loosened at the stem bone interface and recommended a revision surgery.

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 - (b)(4), packaged and released by: monument, release to warehouse date: 19-nov-2014, expiration date: 31-oct-2019, part number: 04.402.007s, 7mm ti straight radial stem 26mm ¿ sterile, lot number: 7683416 (sterile), lot quantity: 148.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign dated 27-oct-2014 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 found to be conforming with no deviations to normal packaging identified.Scn 10785 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: 21014, tialnbri16.00, lot number: 7557656, lot quantity: 3,059 lbs.Certified test report supplied by perryman company dated 22-nov-2013 and inspection certificate supplied by vsmpo dated 25-jun-2012 were reviewed and determined to be conforming.Lot summary report dated 12-dec-2013 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.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.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.H10 additional narrative: b5: updated event descrition.H3, h6: investigation summary.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.Device history lot: manufacturing location: supplier - (b)(4) / inspected, packaged and released by: monument; release to warehouse date: nov 19, 2014; expiration date: oct 31, 2019; part number: 04.402.007s, 7mm ti straight radial stem 26mm ¿ sterile; lot number: 7683416 (sterile); lot quantity: 148.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign dated oct 27, 2014 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, (b)(4) rev b met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev a was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Scn (b)(4) 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: 21014, tialnbri16.00; lot number: 7557656; lot quantity: 3,059 lbs.Certified test report supplied by perryman company dated nov 22, 2013 and inspection certificate supplied by vsmpo dated jun 25, 2012 were reviewed and determined to be conforming.Lot summary report dated dec 12, 2013 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review: oct 17, 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

It was reported that on (b)(6) 2018, the patient underwent a revision using a non-synthes radial head prosthesis system.During the surgery, the physician(s) inspected the synthes radial head prosthesis system and determined that it had in fact loosened and was entirely unstable.There was a significant bone loss requiring a complete left elbow revision.Subsequent to the surgery, the patient suffered nerve injury, loss of sensory and motor control, arthritic issues, permanent strength and control loss, and other related complications.On (b)(6) 2015, the patient fell at work and found to have ulno-humeral subluxation and radial head fracture and was placed into a splint.Complains of pain in the left elbow with numbness.On or about (b)(6) 2015, the patient underwent a surgery to repair a radial head fracture in the left arm and was implanted with a synthes radial head prosthesis system.Postoperatively, despite extensive physical therapy and use of brace, patient still was diagnosed with left elbow arthrofibrosis and so a manipulation under anesthesia was performed on (b)(6) 2015.On (b)(6) 2015, just about 3 months status post left radial replacement for fracture, patient complained of continued pain in his elbow, catching sensations in the elbow and wrist, and difficulty with range of motion.On (b)(6) 2016, x-rays of the left elbow showed loosening around the radial head replacement until 2018, patients complained of left elbow stiffness, chronic pain in the left elbow, pain and weakness in the left wrist.On or about (b)(6) 2018, the patient¿s physicians determined that the implanted synthes radial head prosthesis loosened at the stem bone interface and recommended a revision surgery.

• Brand Name: 7MM TI STRAIGHT RADIAL STEM 26MM-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: 8371262
• MDR Text Key: 137193828
• Report Number: 2939274-2019-56678
• Device Sequence Number: 1
• Product Code: KWI
• 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
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 04.402.007S
• Device Lot Number: 7683416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 106