MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 43/22 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Model Number	75018942
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a first revision surgery had been performed on (b)(6) 2013, the patient had another dislocation (it was stated that the patient was non-compliant).A second revision surgery was performed on (b)(6) 2021 to replace the 43mm xlpe insert 43mm/22mm.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that, after a first revision surgery had been performed on (b)(6) 2013, the patient had another dislocation.A second revision surgery was performed on (b)(6) 2021 to replace 43mm cemented polarcup, the 43mm xlpe insert 43mm/22mm and the oxinium head 22mm +8mm.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.Based on the limited information provided, a thorough medical assessment could not be performed.One additional complaint was reported for the batch in question.However, this complaint was reported for another issue.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.The instructions for use (lit.No.12.23 ed 05/16) lists dislocation 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 dislocation 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 43/22 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11812815
• Report Number: 9613369-2021-00206
• Device Sequence Number: 3223529
• Product Code: LPH
• UDI-Device Identifier: 07611996111323
• UDI-Public: 07611996111323
• 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: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 04/27/2017
• Device Model Number: 75018942
• Device Catalogue Number: 75018942
• Device Lot Number: B1016409
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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: Required Intervention