MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 15; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY

Catalog Number	71421511
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Failure of Implant (1924); Limited Mobility Of The Implanted Joint (2671)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery for poly replacement since patient was loose in flexion.When surgeon opened the knee, he found a piece of chipped poly on posterior side.
Additional Manufacturer Narrative
The associated genesis ii ps high flexion insert was not returned for evaluation.A clinical investigation noted that no clinical relevant information has been provided to conduct a thorough analysis of the reported issue.A medical assessment cannot be rendered.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.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.Should additional information be received, the complaint will be reopened.

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 15
• 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: 7320479
• Report Number: 1020279-2018-00271
• Device Sequence Number: 110126
• Product Code: JWH
• UDI-Device Identifier: 03596010492937
• UDI-Public: 03596010492937
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/03/2018

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: Health Professional
• Device Catalogue Number: 71421511
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 05/03/2018
• 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: Hospitalization; Required Intervention