MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM; PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINDCMNTDPOLYMERMETALPOLYMER

Model Number	74027241
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to instability.Poly was exchanged.
Event or Problem Description
It was reported that a revision surgery was performed due to instability.Femoral and tibial implants were tested for looseness and were found to be well fixed.Poly was exchange.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that it was reported that a revision surgery was performed due to instability.It is noted, the implant will not be received and no further information is available.Without any supporting medical documentation, the reported event cannot be assessed and a thorough medical assessment cannot be performed.In the event the medical/clinical records are received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of this event could include a device fit or sizing issue.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM
• Common Device Name: PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINDCMNTDPOLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9631632
• Report Number: 1020279-2020-00380
• Device Sequence Number: 19621603
• Product Code: JWH
• UDI-Device Identifier: 00885556177617
• UDI-Public: 00885556177617
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2020

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 Model Number: 74027241
• Device Catalogue Number: 74027241
• Device Lot Number: 17BM01112
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/13/2020; 01/13/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/11/2020; 04/06/2020
• 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