MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71932637
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to failure of genesis ii 7.5mm resurfacing patella 35mm.The patella was disassociated from bone resulting in need for revision surgery.No acute fall, injury or adverse event prior to revision surgery was reported.Stryker simplex hv with gent were used for patella.The surgeon also concerned with the amount of "pitting" on the poly after only 4 years of primary implantation.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode, but could confirm the device is heavily gouged on the inferior surface and scratches on the articular surface.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The clinical evaluation noted that the complaint reports a revision of the resurfacing patella due to disassociation.The requested x-rays and surgical reports have not been provided to date.Without adequate documentation/information, the root cause of the reported events cannot be fully evaluated.Therefore, the patient impact beyond the reported revision cannot 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.Some potential causes of the reported event could include but are not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should 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: GEN II 7.5MM RESUR PAT 35MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10433856
• Report Number: 1020279-2020-04095
• Device Sequence Number: 14018018
• Product Code: JWH
• UDI-Device Identifier: 00885556057117
• UDI-Public: 885556057117
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2021

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 Catalogue Number: 71932637
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 05/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LGN XLPE PS INSERT SZ 5-6 9MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 117