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 Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event reported as (b)(6) 2016, exact date of device loosening is not known.A review of the device history records has been requested.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.Patient code (b)(4)-no code available used to capture required intervention.The device loosened post-operatively requiring additional surgery.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 the patient underwent removal of right radial head prosthesis system on (b)(6) 2017.Patient underwent open reduction and internal fixation on (b)(6) 2016 and was implanted with radial head prosthesis system due to broken right elbow that happened in an adult relay type race in which patient was on a set of monkey bars and fell to the ground.On (b)(6) 2016 pre-operative computed tomography (ct) scan taken and revealed severely comminuted, intra-articular fracture head and neck with a large joint effusion.Initial surgery was successful, patient was in stable condition with no complications.On (b)(6) 2017 bone scan revealed lucency around the stem of the radial head prosthesis.On (b)(6) 2017, during the follow up visit, patient had not progress in motion and having a lot of pain.On an unknown date, patient had a postoperative x-rays that showed osteolysis around the stem of the radial head prosthesis and the radial head prosthesis was pistoning in the bone based on the x-rays.During revision procedure, the tissue around the joint was noted to very hypertrophic.The radial head implant was noted to be very loose and was spinning freely around the bone and has also pistoned out more proximally up against the capitellum.The radial head was disarticulated from the stem.The head was removed and the stem was removed and came out without any difficulty.There was absolutely no bonding to the bone with it.The removal surgery was successfully completed without any issues or delay and the patient was reported as stable.This report is for one (1) 22mm radial head this is report 2 of 2 for (b)(4).

Manufacturer Narrative

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.A review of the device history records has been requested.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.Device evaluated by mfr, device manufacture date: device history records review was completed for part#: 09.402.022s, lot#: 7785181.Manufacturing location: monument, manufacturing date: mar 09, 2015, expiry date: jan 31, 2020.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of compliance supplied by avalign dated jan 30, 2015 was reviewed and determined to be conforming.Packaging label log lppf, lmd/lpf was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Scn supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility 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 parts reviewed: part: 21022, lot: 5345317 product traveler met all inspection acceptance criteria.Inspection sheet, raw material inspection, met all inspection acceptance criteria.Test analysis supplied by ummc/biomedical materials science dated sep 29, 2006 was determined to be conforming.Certified test report supplied by perryman company dated sep 18, 2006 was determined to be conforming.Inspection certificate supplied by vsmpo dated jul 14, 2006 was determined to be conforming.Raw material receiving / putaway checklist met all inspection acceptance criteria.Part: 41060, lot: 7695678 certificates of test supplied by carpenter dated may 09, 2014 and apr 29, 2014 were determined to be conforming.Lot summary report dated may 20, 2014 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device evaluated by mfr: the x-rays were reviewed and based on the x-rays alone, this complaint could not be confirmed.However, there are known issues with the radial head implants and relevant actions have been initiated to address them.Based on these information the complaint for loosening can be confirmed.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The complaint condition is confirmed.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 image that may have contributed to the 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.

• 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: 7952173
• MDR Text Key: 123252934
• Report Number: 2939274-2018-54287
• 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
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 09.402.022S
• Device Catalogue Number: 09.402.022S
• Device Lot Number: 7785181
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 73