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

Model Number	75018942
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that revision surgery was performed due to dislocation.The polarcup xlpe insert 43/22 non-cem was removed and replaced with another insert of the same size.
Additional Manufacturer Narrative
It was reported that revision surgery was performed due to dislocation.The device intended for use during treatment was not returned for investigation nor was a batch number communicated.Therefore an appropriate investigation could not be conducted and the reported issue not independently be confirmed.The ifu (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 available information the root cause cannot be determined.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.The complaint will be reopened should the complained device or additional information be received.

• Brand Name: POLARCUP XLPE INSERT 43/22 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10621588
• Report Number: 9613369-2020-00196
• Device Sequence Number: 11083146
• Product Code: LPH
• UDI-Device Identifier: 07611996111323
• UDI-Public: 07611996111323
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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: 75018942
• Device Catalogue Number: 75018942
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 10/19/2020
• 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