MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TC PRIM/TC REV TIB INS TC CS ULTRAC 6/11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTEDA

Model Number	75006076
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During knee replacement surgery, the insert of 6/11 could not be placed in the posterior slot of tibial baseplate, resulting in insert damage.Finally a insert of 6/9 was used to complete the surgery.No extra bone cuts were made to place 6/9 insert.Delay greater than 30 minutes was recorded.
Additional Manufacturer Narrative
A tc prim/tc rev tib ins tc cs ultrac 6/11 was reported due to failure/difficulty to interlock during a revision surgery.The device was used in treatment.The complaint device was returned.The visual inspection could confirm the damage on the insert which was caused when the insert could not be placed in the posterior slot of tibial baseplate.The dimensional evaluation did not detect dimensional deviations prior to the surgery.The complaint history review did not find any further complaints concerning devices of the same batch.No deviations from the standard operating procedure was found in the production documentation review.Based on the conducted investigation, the root cause could not be determined conclusively.If more information becomes available, the complaint will be re-evaluated.Smith+nephew will continue to monitor for similar issues.The complaint device will be discarded.

• Brand Name: TC PRIM/TC REV TIB INS TC CS ULTRAC 6/11
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTEDA
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9567155
• Report Number: 9613369-2020-00006
• Device Sequence Number: 16700409
• Product Code: JWH
• UDI-Device Identifier: 07611996009231
• UDI-Public: 07611996009231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2025
• Device Model Number: 75006076
• Device Catalogue Number: 75006076
• Device Lot Number: J1809451
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1