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

Model Number	75005997
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka on her left knee in 2012, the patient felt knee instability, a revision surgery was performed on (b)(6) 2021 to exchange a tc prim tibial insert tc cr stand 6/11, due to, the insert he/she was carrying was broken.The current health status of patient is unknown.The device will be returned for evaluation to the smith + nephew barcelona warehouse.
Additional Manufacturer Narrative
D4: expiration date d4: lot information.
Additional Manufacturer Narrative
Results of investigation: it was reported that, after a total knee arthroplasty on her left knee in 2012, the patient felt knee instability, a revision surgery was performed on (b)(6) 2021 to exchange a tc plus primary tibial insert.The device, used in treatment, was returned for evaluation.The insert shows some delamination at the anterior section of the device.Furthermore, the insert shows signs of use.The device history was reviewed.The product documentation does not indicate that the part failed to match specification at the time of manufacturing.A complaint history review did not reveal any further complaint for the batch in scope.The failure mode and the severity of the reported issue are covered through the corresponding risk file.Abrasion of implant surfaces are listed among the possible side effects of knee implants according to ifu, which was current at the time of manufacturing.A medical assessment concludes that the provided x-rays support the reported knee instability.However, the root cause of the reported instability cannot be determined.Based on the available information, the relationship between the event and the device can be confirmed.The root cause stays undetermined after investigation and it cannot be speculated about factors which could have contributed to the reported issue.To date, no further actions are deemed necessary.The device will be monitored for further similar issues.The returned device will be retained.

• Brand Name: TC PRIM TIBIAL INSERT TC CR STAND 6/11
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12043068
• Report Number: 9613369-2021-00309
• Device Sequence Number: 4000785
• Product Code: JWH
• UDI-Device Identifier: 07611996008708
• UDI-Public: 07611996008708
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K000666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2021

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: 05/26/2017
• Device Model Number: 75005997
• Device Catalogue Number: 75005997
• Device Lot Number: I1019039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 11/22/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 11/08/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Female