MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 47/28 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75018955
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that liner disassociated from head when the lip of the cup interposed itself between the liner and head.Both devices were reassembled with no success.Surgeon decided to use entire new implants since no backup was available.Delay no greater than 30 minutes was reported.
Additional Manufacturer Narrative
It was reported that a polarcup liner disassociated from head when the lip of the cup interposed itself between the liner and head.Both devices were reassembled with no success.The device intended for use 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.A review of the batch record revealed no deviation from the standard manufacturing process that could explain the reported disassociation of the femoral head from the polarcup liner.A review of the complaint history revealed no other complaint for the batch in scope nor similar issues for the device in question.There is no indication that the device 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.Smith + nephew will continue to monitor the devices for similar issues.The complaint will be reopened should the devices in scope be returned or additional information be received.

• Brand Name: POLARCUP XLPE INSERT 47/28 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: 9568380
• Report Number: 9613369-2020-00008
• Device Sequence Number: 18939643
• Product Code: LPH
• UDI-Device Identifier: 07611996111453
• UDI-Public: 07611996111453
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2025
• Device Model Number: 75018955
• Device Catalogue Number: 75018955
• Device Lot Number: B1817827
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1