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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed, 4 weeks after thr.Due to infection, head and liner were exchanged.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed four weeks after thr.Due to infection.The xlpe insert used in treatment was not returned for investigation.An appropriate investigation could therefore not be conducted and the reported failure mode could not independently be confirmed.It was communicated that consent has not been granted by the patient for clinical/medical records to be released and included in this assessment.Therefore, a clinical assessment cannot be performed and the patient impact beyond the revision surgery cannot be concluded.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported infection.A review of the complaint history revealed no other complaint for the batch in question.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 sterilization or other specifications 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 device for similar issues.The complaint will be reopened should the complained device or additional information 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; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9687340
• Report Number: 9613369-2020-00022
• Device Sequence Number: 11618707
• Product Code: LPH
• UDI-Device Identifier: 07611996111460
• UDI-Public: 07611996111460
• Combination Product (Y/N): N
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2020

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: 08/21/2026
• Device Model Number: 75018956
• Device Catalogue Number: 75018956
• Device Lot Number: B1917935
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 04/05/2020
• 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: Required Intervention