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
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during b/l thr, one plug cover of the polarcup shell ti-plasma/ha 51 non-cem could not be removed and the polarcup shell ti-plasma/ha 51 non-cem suffered a deformation while trying to unpluged the cover.No significant delays were reported and the procedure was finished with a smith and nephew back up device.No patient was harmed.
Additional Manufacturer Narrative
H3, h6: it was reported that during surgery one of the plug covers of the polarcup shell ti-plasma/ha 51 non-cem (75100440) could not be removed.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 51 NON-CEM
• Common Device Name: 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: 11814116
• Report Number: 9613369-2021-00210
• Device Sequence Number: 19639220
• Product Code: LPH
• UDI-Device Identifier: 07611996118315
• UDI-Public: 07611996118315
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 75100440
• Device Catalogue Number: 75100440
• Device Lot Number: B2014029
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/24/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1