MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TC PRIM TIBIAL INSERT TC CR STAND 6/11; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENT,POLY/METAL/POLY

Catalog Number	75005997
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery of the tibial insert tc cr stand 6/11.
Additional Manufacturer Narrative
Results of investigation: a revision surgery was reported due to the loosening of a tc primary insert.The reported pe insert was returned.Wear patches are observed on the articulating surface of the insert (both condyles).Weak yellow discolorations are observed on the underside of the insert.The yellow discoloration are roughly located vertically under the wear patches.Scratches and dents typical of the explantation procedure are observed.A review of the production documentation did not detect any deviation from the standard manufacturing processes.No similar complaint was reported for this batch of products.No medical documents were communicated.Based on the available information, the root cause of the reported issue remains undetermined.There is however to the best of our knowledge no indication that the device failed to meet specifications at the time of manufacturing.No further actions have been initiated.If additional information becomes available in the future this investigation will be reopened.

• Brand Name: TC PRIM TIBIAL INSERT TC CR STAND 6/11
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENT,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar, 06340 ; SZ 06340
• MDR Report Key: 7844471
• Report Number: 1020279-2018-01696
• Device Sequence Number: 2468932
• Product Code: JWH
• UDI-Device Identifier: 07611996008708
• UDI-Public: 07611996008708
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K000666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2018

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: Lay User/Patient
• Device Catalogue Number: 75005997
• Device Lot Number: 0510.13.5618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 12/24/2018
• 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
• Patient Age: 76 YR