MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL TI-PLASMA/HA 53 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	75100441
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the studs shutters was unable to be unscrewed.After several attempts, the thread got deteriorated.A delay greater than 30 minutes was recorded.Smith and nephew backup was available.
Additional Manufacturer Narrative
Additional info: d10, g7, g9, h2, h3, h6, h10 results of investigation: it was reported that one of the plugs was unable to be unscrewed.According to the complainant, after several attempts, the thread got deteriorated.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 risk management file indicates that the associated risk level is low.A review of the complaint history revealed no other complaint being reported for the batch in question.A review for the whole device family revealed similar complaints being reported for plug removal issues since (b)(6) 2019.All complaints are reported for other batches and a review of the batch record revealed no deviations that could have contributed to the reported issue.Based on available information the root cause for the reported jamming cannot clearly be identified and stays undetermined.However, the executed investigation steps give no indication that the device failed to match specification at the time of manufacturing and 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 be received.

• Brand Name: POLARCUP SHELL TI-PLASMA/HA 53 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 10078434
• Report Number: 9613369-2020-00091
• Device Sequence Number: 16905314
• Product Code: LWJ
• UDI-Device Identifier: 07611996118322
• UDI-Public: 07611996118322
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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 Model Number: 75100441
• Device Catalogue Number: 75100441
• Device Lot Number: B1922758
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 07/02/2020
• 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: 75023347 T-HANDLE UNIDIRECTIONAL, LOT UNK; 75023347 T-HANDLE UNIDIRECTIONAL, LOT UNK