MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL TI-PLASMA/HA 51 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 75100440

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Event Description

It was reported that when doctor opened polarcup shell, he opened the screws to get pegs.Nuts on the polarcup shell cannot be opened despite attempt of unscrewing and screwing for opening.The procedure was completed using a sn backup device.No surgical delay or injury to the patient was reported.

Manufacturer Narrative

Results of investigation: it was reported that the plugs of the polarcup shell ti-plasma/ha 49 non-cem (75100439) were found blocked.The procedure was completed using a smith+nephew backup device.No surgical delay or injury to the patient was reported.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 both plugs are observed to be heavily damaged, indicating that high torque was applied.Both plugs are observed to be recessed, indicating that they could initially be turned before getting jammed.A review of the complaint history revealed no other complaint being reported for the batch in question.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported failure mode.The surgical technique (lit no.01620-en (1582) v7 10/20) describes the correct removal of the polarcup plugs using the unidirectional t handle (75023347): "release the plugs by turning the t wrench in the direction indicated on the plug cover." the ifu (lit.No.12.23 ed 05/16) states: "the following might not be implanted under any circumstances: implant components that have been damaged or scratched; implants that have been handled inappropriately or processed in a way that is not part of the surgical technique".The current risk analysis covers the risk of jamming between plug and shell.The associated risk level is considered low.Based on available information the root cause for the reported jamming cannot clearly be identified and stays undetermined.However, the executed investigation gives 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 51 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11450006
• MDR Text Key: 239750942
• Report Number: 9613369-2021-00106
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07611996118315
• UDI-Public: 07611996118315
• Combination Product (y/n): N
• PMA/PMN Number: K122244
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75100440
• Device Catalogue Number: 75100440
• Device Lot Number: B1717720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1