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

Catalog Number	75018942
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this is 3rd revision of hip (previous product experience).Patient dislocated hip.
Additional Manufacturer Narrative
Results of investigation: a dislocation/ luxation was reported with a polarcup xlpe insert 22/43.The device in question was not sent back for investigation and a product evaluation could not be conducted.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported failure mode.A review of the complaint history revealed no other complaints for the batch in question.One other complaint with similar issue has been reported for the device.No supporting clinical documents were provided to conduct a thorough medical investigation.Therefore based on insufficient information, a thorough clinical assessment could not be performed.The stated failure mode could not be confirmed.The root cause of reported dislocation/ luxation cannot clearly be reproduced and stays undetermined.Based on available information the need for corrective action is not indicated.The complaint will be reopened should additional information be received.Smith and nephew will continue to monitor this device for similar issues.
Event or Problem Description
It was reported that this is the third revision due to hip dislocation.

• Brand Name: POLARCUP XLPE INSERT 22/43
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 8453615
• Report Number: 1020279-2019-01210
• Device Sequence Number: 11510557
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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 Catalogue Number: 75018942
• Device Lot Number: B1820315
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OXINIUM FEMORAL HEAD PN: 71342208 LN:15EM19894
• Outcome Attributed to Adverse Event: Congenital Anomaly; Hospitalization