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

Catalog Number	75018956
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the femoral head dislocated from the polar xlpe liner.Head remained attached to the stem taper.Revision of femoral head and therefore liner and cemented polar shell was also changed.
Additional Manufacturer Narrative
Results of investigation: a dislocation of a polarcup xlpe insert was reported.No part was returned for investigation.A review of the production documentation did not detect any deviation from the standard manufacturing processes.No similar complaint was reported for this batch of products.The available medical documents were reviewed.The provided fluoroscopic image shows the dislocation.The image is of too low quality to identify possible contributing factors.Based on the available information, no thorough investigation could be performed and the root cause of the reported issue remains undetermined.There is however to the best of our knowledge no indication that the device failed to meet specifications at the time of manufacturing.No further actions have been initiated.If the explants or additional information becomes available in the future this investigation will be reopened.

• 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: 7958917
• Report Number: 9613369-2018-00067
• Device Sequence Number: 18939433
• Product Code: LPH
• UDI-Device Identifier: 07611996111460
• UDI-Public: 07611996111460
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 08/01/2024
• Device Catalogue Number: 75018956
• Device Lot Number: B1711337
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 12/11/2018
• 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
• Patient Age: 71 YR
• Patient Weight: 70