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

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2020

Event Type  malfunction  

Event 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.

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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 10078434
• MDR Text Key: 191676589
• Report Number: 9613369-2020-00091
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996118322
• UDI-Public: 07611996118322
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 75100441
• Device Catalogue Number: 75100441
• Device Lot Number: B1922758
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 75023347 T-HANDLE UNIDIRECTIONAL, LOT UNK; 75023347 T-HANDLE UNIDIRECTIONAL, LOT UNK