MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 43/22 NON-CEM; 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	10/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to consistent dislocation.Patient was non compliant.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to dislocation.The complained devices have not been returned for investigation.It has been communicated that no content been granted for the patients¿ medical history and medical records.Based on insufficient information, a thorough clinical assessment could not be performed.A review of the complaint history revealed two additional complaints for the batch (b1901711) of the polarcup xlpe insert.However, a review of the batch record revealed no deviation from the standard manufacturing process for both in scope devices.The ifu (lit.No.12.23 ed 05/16) states "dislocation" as a known possible side effect in combination with the implantation of a hip prosthesis.There is no indication that the devices failed to match specification at the time of manufacturing.Based on available information the root cause for the reported issue cannot be identified and stays undetermined.The need for corrective action is not indicated.Nevertheless, s+n will continue to monitor the devices for similar issues.The complaint will be reopened should additional information become available.

• 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; baar 06340 ; SZ 06340
• MDR Report Key: 9253399
• Report Number: 9613369-2019-00085
• Device Sequence Number: 19298953
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2019

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 Expiration Date: 01/22/2026
• Device Catalogue Number: 75018942
• Device Lot Number: B1901711
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 12/29/2019
• 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