MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 32MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Model Number	71932636
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patella and insert were removed due to the patella being loose after a fall.Poly was exchanged but no problems were associated with the device.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A clinical analysis indicated that the case reports this patient implant became loose after a reported fall.However, without the relevant requested clinical information, we are unable to confirm the reported loosening.Should any additional clinical information be provided this complaint will be re-assessed.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 complaint history for the listed part revealed no prior complaints about the listed failure mode with the same batch number.A review of the risk management file and instructions of use for the product was completed.Factors and/or some potential probable causes that could include but not limited to abnormal motion over time, bone degeneration fit/sizing, lack of ingrowth, and traumatic injury.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GEN II 7.5MM RESUR PAT 32MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9526018
• Report Number: 1020279-2019-04605
• Device Sequence Number: 2769137
• Product Code: JWH
• UDI-Device Identifier: 00885556056721
• UDI-Public: 00885556056721
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: No Information
• Device Model Number: 71932636
• Device Catalogue Number: 71932636
• Device Lot Number: 17DM14201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 09/29/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74027246, JRNY II BCS ISRT 15MM, 16HM14929
• Outcome Attributed to Adverse Event: Required Intervention