MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	75100442
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cup installation, a problem was encountered when removing one of the plugs that cover the holes for the anchor studs.The cover could not be removed and the acetabulum was not placed.A competitor device was used to complete the procedure and no delay was reported.
Additional Manufacturer Narrative
It was reported that during a cup installation, a problem was encountered when removing one of the plugs.The complained device has been returned for investigation.The reported failure mode could be confirmed upon visual inspection.The left plug is stuck with the polarcup.The hexagon head of the plug is observed to be heavily damaged, indicating that high torque has been applied.As the plug could not be removed, it is not possible to clarify whether the plug got cold-welded.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported failure mode.A review of the complaint history revealed no other complaint for the batch in scope nor for a similar issue for the device.A review of the complaint history for the whole device family revealed 11 complaints being reported for issues related to removal of the plug since 2015.However, the occurrence of this issue is still low, based on current sales data.The executed investigation steps give no indication that the device failed to match specification at the time of manufacturing.It is not possible to determine the root cause for the reported jamming conclusively.The root cause stays therefore undetermined after investigation.The need for corrective action is not indicated.Smith + nephew will continue to monitor this device for similar issues.The returned device will be retained.

• Brand Name: POLARCUP SHELL TI-PLASMA/HA 55 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: 9378767
• Report Number: 9613369-2019-00095
• Device Sequence Number: 3170858
• Product Code: LWJ
• UDI-Device Identifier: 07611996118339
• UDI-Public: 07611996118339
• Combination Product (Y/N): N
• PMA/510(K) Number: K122244
• 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): 01/02/2020

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 Expiration Date: 03/27/2026
• Device Catalogue Number: 75100442
• Device Lot Number: B1906958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1