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

Model Number	75100442
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before a thr procedure the polarcup shell ti-plasma/ha 55 non-cem lug caps were found blocked.The caps do not unscrew.No procedure-related.S+n backup device available.No injuries or surgical delays reported.
Additional Manufacturer Narrative
Results of investigation: it was reported that before a thr procedure the plugs of the polarcup shell ti-plasma/ha 55 non-cem (75100442) were found blocked.The device used in treatment was returned for investigation.The reported issue could be confirmed upon visual inspection.Both plugs are stuck with the polarcup.The hexagon head of the plug is observed to be heavily damaged, indicating that high torque was applied.The plugs are both observed to be recessed, indicating that it could initially be turned before getting jammed.A picture of the used t-handle was also provided, showing the hexagon head to be highly worn.It cannot be concluded whether the t-handle hexagon head was already worn when trying to remove the polarcup plugs.A worn hexagon head might contribute to issues during plug extraction.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 being reported for the batch in question.A review of the risk management file indicates that the associated risk level is low.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.Nevertheless, 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, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10580931
• Report Number: 9613369-2020-00182
• Device Sequence Number: 1218876
• Product Code: JDI
• UDI-Device Identifier: 07611996118339
• UDI-Public: 07611996118339
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75100442
• Device Catalogue Number: 75100442
• Device Lot Number: B1927164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1