MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 26MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	71420580
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery of the patellar component was performed due to patella tilt and lateral patella pain.
Additional Manufacturer Narrative
The associated complaint device was returned for evaluation.Given the initial intra-operative patellar tracking difficulty, return of pain 6 months post-op, and 6 months until revision, currently unable to rule out the underlying mal-alignment and/or tissue laxity as possible contributing factors to the reported patellar tilt/lateral mal-tracking.Should additional information become available, the clinical/medical assessment may be re-evaluated.Evaluation of the returned device revealed minor scratches on the articular surface of the patella implant which could have been caused by third-body particulate (bone, bone cement, etc.) or during removal of the implant.The side view of the patella implant shows a damaged fixation post with a large cut originating from one side.Visible scratch patterns on the missing post location make it difficult to determine whether this post was removed during implant excision or fractured while implanted.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 26MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7331060
• Report Number: 1020279-2018-00302
• Device Sequence Number: 1605106
• Product Code: JWH
• UDI-Device Identifier: 03596010208323
• UDI-Public: 03596010208323
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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 Expiration Date: 02/15/2020
• Device Catalogue Number: 71420580
• Device Lot Number: 10BM10025
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 02/12/2019
• 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
• Patient Age: 73 YR