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

Model Number	75018956
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, a revision surgery was performed with a routine wash-out and component exchange due to infection.Patient outcome is unknown.
Additional Manufacturer Narrative
It was reported that, a revision surgery was performed with a routine wash-out and component exchange due to infection.The polarcup xlpe insert 49/28 non-cem (75018956) intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted and the reported failure mode could not independently be confirmed.Based on the limited information provided, a thorough medical assessment could not be performed.A review of the complaint history revealed no additional complaint for the batch in question.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.The instructions for use lists infection 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 for the reported infection is attributed to a known inherent risk of the device.However, the executed investigation gives no indication that the device failed to match specification at the time of manufacturing.The need for corrective action is therefore not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: POLARCUP XLPE INSERT 49/28 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: 11478998
• Report Number: 9613369-2021-00115
• Device Sequence Number: 11616181
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: 75018956
• Device Catalogue Number: 75018956
• Device Lot Number: B2014068
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/14/2021
• Supplement Report FDA Received Date: 05/04/2021
• 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