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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 09/08/2020

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 209636362
• Report Number: 9613369-2020-00196
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07611996111323
• UDI-Public: 07611996111323
• Combination Product (y/n): N
• PMA/PMN Number: K110135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 75018942
• Device Catalogue Number: 75018942
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention