MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Catalog Number	74027231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that due to instability the patient required a revision surgery to exchange the insert.It's unknown the status of the patient.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.Per complaint details, an insert revision/exchange was performed due to instability approximately 7 years post implantation.S+n has not received the device and/or adequate documentation to fully evaluate the root cause of the reported event.The patient impact beyond the reported instability and revision could not be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to fit/sizing issue, lifetime of device or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10127387
• Report Number: 1020279-2020-02145
• Device Sequence Number: 3816671
• Product Code: JWH
• UDI-Device Identifier: 00885556179017
• UDI-Public: 885556179017
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2022
• Device Catalogue Number: 74027231
• Device Lot Number: 12GM14410
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR