MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 29MM; PRSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR

Catalog Number	71932635
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Information (3190)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was told by her doctor that a surgical intervention could be performed in the future.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical concluded, based on the limited information provided, the patient's nickel allergy was reported as the reason for the revision of the nickel-containing patellar o-ring 8 months after the primary left tka.The patient impact beyond the reported pain and revision procedure cannot be determined.No further medical assessment can be rendered at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.
Event or Problem Description
It was reported that a surgical intervention was performed due to pain.The patella was exchanged.

• Brand Name: GEN II 7.5MM RESUR PAT 29MM
• Common Device Name: PRSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7441659
• Report Number: 1020279-2018-00772
• Device Sequence Number: 16417050
• Product Code: JWH
• UDI-Device Identifier: 00885556056516
• UDI-Public: 00885556056516
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2018

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: 71932635
• Device Lot Number: 17FM01973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 03/23/2018; 03/23/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 06/12/2018; 07/10/2018
• 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: Other; Required Intervention