MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 32MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY

Catalog Number	71420576
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was operated on (b)(6) 2012 and after 6 years patella was slightly lateralized.One of the three plugs in the patella come out from the implant.
Additional Manufacturer Narrative
The associated complaint device was returned for evaluation.Based on the information provided, the root cause cannot be concluded, however, it is unknown if the patient experienced any prior trauma which could have contributed to the reported event.The patient impact beyond the reported patellar revision and post-op exercises cannot be concluded.No further medical assessment can be rendered at this time.Evaluation of the returned gii resurfacing patellar prosthesis revealed that the articular surface of is mostly undamaged with only minor wear around the periphery of the articular surface.Two fixation posts are damaged and one is mostly missing.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing abnormalities 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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GNS II RESURF PAT 32MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7391320
• Report Number: 1020279-2018-00706
• Device Sequence Number: 16407945
• Product Code: JWH
• UDI-Device Identifier: 03596010485069
• UDI-Public: 03596010485069
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: Physician
• Device Expiration Date: 01/22/2022
• Device Catalogue Number: 71420576
• Device Lot Number: 12AM15028
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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: Required Intervention