MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TC PRIM FIXED TIB INSERT VKS CS LT 4/14; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	75000328
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka system had been implanted on (b)(6), the patient experienced joint laxity on an unspecified date.A revision surgery was performed on (b)(6) 2022 to address this event.The tc prim fixed tib insert vks cs lt 4/14 was exchanged.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that, after a total knee arthroplasty in 2009, the patient experienced joint laxity on an unspecified date.The device, used in treatment, was returned for investigation.Upon visual inspection, the device shows scratch marks and dents on the articulating as well as on the distal implant surface.The scratch marks potentially origin from the revision surgery.Apart from that, the insert looks fully functional and the locking mechanism of the device at the distal side looks intact.No additional complaint for the batch in scope was reported so far.A review of the production documentation did not reveal any deviation from the standard operating procedure.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the provided information, a clinical investigation to fully evaluate the complaint was not possible.A review of past corrective actions was performed.No further escalation is required.A review of the device labeling reveals that the ifu (lit.No.Lit.No.12.24, ed.03/21) states joint instability as a potential adverse device effect in combination with the implantation of a knee prosthesis.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.Based on the performed investigations, the relationship between the reported event and the device could not be confirmed and the root cause could not be determined conclusively.Should more information become available, the investigation will be reopened.No further actions are deemed necessary at this time.Smith+nephew will continue to monitor this device for similar issues.The returned device will be archived.Internal complaint reference: (b)(4).

• Brand Name: TC PRIM FIXED TIB INSERT VKS CS LT 4/14
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 13653966
• Report Number: 9613369-2022-00045
• Device Sequence Number: 5749693
• Product Code: JWH
• UDI-Device Identifier: 07611996094077
• UDI-Public: 07611996094077
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K072858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2015
• Device Model Number: 75000328
• Device Catalogue Number: 75000328
• Device Lot Number: A0711571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2008
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown