MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL TI-PLASMA/HA 59 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 75100444

Device Problem Mechanical Jam (2983)

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

Event Date 04/28/2021

Event Type  Injury  

Event Description

It was reported that during a thr, the plug cover of a polarcup shell ti-plasma/ha 59 non-cem couldn't be removed and was worn out while being unplugged.There was a delay of 30 minutes or less and there was a change of surgical procedure due to the failure.Patient was not harmed.

Manufacturer Narrative

H3, h6: it was reported that during a thr, the plug cover of a polarcup shell ti-plasma/ha 59 non-cem (75100444) couldn't be removed and was worn out while being unplugged.The device intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted and the reported failure mode could not independently be confirmed.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 the performed investigations, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.A worn t-handle is known to contribute to the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.Based on available information the root cause for the reported jamming cannot clearly be identified and stays undetermined.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: POLARCUP SHELL TI-PLASMA/HA 59 NON-CEM
• Type of Device: 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: 11843411
• MDR Text Key: 251235895
• Report Number: 9613369-2021-00228
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07611996118353
• UDI-Public: 07611996118353
• Combination Product (y/n): N
• PMA/PMN Number: K122244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2021
• Device Model Number: 75100444
• Device Catalogue Number: 75100444
• Device Lot Number: B2006690
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention