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

Model Number	75017221
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a left hip revision surgery was performed due to dislocation.Surgeon found in situ the mobile acetabular insert outside of the prosthetic cup.The dislocation was not reducible, thus walking was impossible and revision surgery was impossible too.Change of cup and insert.Unknown if there was a delay during the procedure.
Additional Manufacturer Narrative
Additional info: g7, g9, h2, h3, h6, h10 result of investigation: it was reported that a revision surgery was conducted due to dislocation of polarcup pe insert (75017221).The device used in treatment was not been returned for investigation.The device could therefore not be evaluated and the stated failure mode not independently be confirmed.To date no medical/clinical documentation has been provided.Without any supporting medical documentation, a thorough medical assessment could not be performed.A review of the batch record revealed no deviations from the standard manufacturing process and a review of the complaint history revealed no similar complaints for the device in question.Based on available information, there is no indication that the device did not meet specification at the time of manufacturing.However, the root cause cannot clearly be identified and stays undetermined.The need for corrective action is not deemed necessary.Nevertheless, smith and nephew will continue to monitor the device for similar issues.The complaint will be reopened should additional information or the device be received.

• Brand Name: POLARCUP PE 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: 9824238
• Report Number: 9613369-2020-00058
• Device Sequence Number: 1300178
• Product Code: LPH
• UDI-Device Identifier: 07611996096460
• UDI-Public: 07611996096460
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K070278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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?: No
• Operator of Device: No Information
• Device Expiration Date: 10/24/2022
• Device Model Number: 75017221
• Device Catalogue Number: 75017221
• Device Lot Number: B1513681
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1