MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 53/28 NON-CEM; PROST, HIP, SEMI-CNSTRAND, METAL/POLY, POROUS UNCMTD

Model Number	75018958
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after thr had been performed on an unknown date, the patient experienced an aseptic loosening.This adverse event was solved by revision surgery on (b)(6) 2021.Current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that, after thr had been performed on an unknown date, the patient experienced an aseptic loosening.This adverse event was solved by revision surgery on (b)(6) 2021.The polarcup xlpe insert 53/28 non-cem used 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.The provided photo was reviewed.However, it does not aid in the medical investigation of the reported "aseptic loosening." based on the limited information provided, a thorough medical assessment could not be performed.No additional complaint was reported 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 loosening 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 the performed investigations, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.The root cause for the reported loosening is attributed to a known inherent risk of the device.The need for corrective action is 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: POLARCUP XLPE INSERT 53/28 NON-CEM
• Common Device Name: PROST, HIP, SEMI-CNSTRAND, METAL/POLY, POROUS UNCMTD
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 12536741
• Report Number: 9613369-2021-00371
• Device Sequence Number: 3431837
• Product Code: LPH
• UDI-Device Identifier: 07611996111484
• UDI-Public: 07611996111484
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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 Model Number: 75018958
• Device Catalogue Number: 75018958
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/11/2021
• 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; Required Intervention