MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM VALGUS TI/HA 4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75102076
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 1 year and 3 months after implantation of the left side of the polar stem, the patient underwent a right tka revision surgery.The date of surgery is unknown.
Additional Manufacturer Narrative
A study reports that approximately 1 year and 3 months after implantation of the left hip with polarstem valgus (75102076), the patient underwent a right tka revision surgery.The device intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted and the reported failure mode could not independently be confirmed.A medical investigation was conducted.Based on the limited information provided, no causal relationship could be established between the tha and the contralateral tka performed on an unknown date approximately 1¼ years post tha and no malperformance of the tha components is supported.Patient impact beyond the reported tka would not be anticipated.No further medical assessment could be rendered at this time.A review of the complaint history revealed no additional complaint for the batch in question.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.The ifu (lit.No.12.23 ed 05/16) lists several adverse issues as a known possible side effect resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on available information the root cause for the reported issue cannot be determined.However, the executed investigation gives no indication that the device failed to match specification at the time of manufacturing.The need for corrective action is therefore not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: POLARSTEM VALGUS TI/HA 4
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11605696
• Report Number: 9613369-2021-00134
• Device Sequence Number: 14317742
• Product Code: LZO
• UDI-Device Identifier: 07611996142365
• UDI-Public: 07611996142365
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 05/31/2024
• Device Model Number: 75102076
• Device Catalogue Number: 75102076
• Device Lot Number: B1708170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/05/2021
• 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; Other; Required Intervention