MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG. POLARCUP XLPE INSERT 61/28 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	75018962
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the polar xlpe insert was revised as part of a total hip revision due to unknown causes.
Additional Manufacturer Narrative
Results of investigation: it was reported that the polar xlpe insert was revised as part of a total hip revision following a peri-prosthetic fracture.The device in scope has not been returned for investigation.A visual inspection could therefore not be conducted and the reported failure mode cannot independently be confirmed.According to the available medical data, the revision was done approximately 6 weeks after a first revision, secondary to a fall that produced a fracture of the diaphyseal femur.All documents and images provided as of this date have been reviewed and consider and unless noted do not contribute to the clinical investigation.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 affected batch nor any reported complaints with similar failure mode for the complained device.Based on the executed investigation steps the indication for the second revision was the trauma-precipitated fracture of the diaphyseal femur and the complained device did most certainly not contribute to the reported failure mode.However, based on available information the root cause cannot clearly be identified and stays undetermined.The need for corrective action is not indicated.Nevertheless, smith and nephew will continue to monitor the devices for similar issues.The complaint will be reopened should additional information or the complained device be received.

• Brand Name: POLARCUP XLPE INSERT 61/28 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: 8384318
• Report Number: 9613369-2019-00016
• Device Sequence Number: 13950798
• Product Code: LPH
• UDI-Device Identifier: 07611996111521
• UDI-Public: 07611996111521
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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: 04/14/2021
• Device Catalogue Number: 75018962
• Device Lot Number: B1405877
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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: POLARCUP PART# 75100415, BATCH# B1709660; POLARCUP PART# 75100415, BATCH# B1709660
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 103