MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 28/49; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75018956
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to infection.All implants were removed.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to infection.The polarcup shell and xlpe insert used in treatment were not returned for investigation.An appropriate investigation could therefore not be conducted and the reported failure mode could not independently be confirmed.Clinically relevant supporting documentation was not provided; therefore, a thorough medical investigation could not be performed.A review of both batch records revealed no deviations from the standard manufacturing process.A review of the complaint history revealed no additional complaints for both batches in scope.The ifu (lit.No.12.23 ed 05/16) identifies "infection" as a known possible side effect resulting from a hip arthroplasty.Based on available information the root cause for the reported infection could not be determined.However, there is no indication that the devices failed to match specification at the time of manufacturing.The associated risk is covered in the risk analysis and considered low.Therefore and based on available information, the need for corrective action is not indicated.Smith + nephew will continue to monitor this devices for similar issues.The complaint will be reopened should the complained devices or additional information be received.

• Brand Name: POLARCUP XLPE INSERT 28/49
• 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: 9280207
• Report Number: 1020279-2019-03881
• Device Sequence Number: 19516400
• Product Code: LPH
• UDI-Device Identifier: 07611996111460
• UDI-Public: 07611996111460
• 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): 03/30/2020

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 Expiration Date: 04/14/2026
• Device Model Number: 75018956
• Device Catalogue Number: 75018956
• Device Lot Number: B1908332
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 03/30/2020
• 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