MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL TI-PLASMA/HA 57 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75100443
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tha, upon opening the sterile packaging of a polarcup shell ti-plasma/ha 57 non-cem, it was tried to remove the plug covers in the direction that was indicated on the plug cover.However, the cap got stuck and could not come out: the thread was damaged.The procedure was completed without delay using a s+n back-up device.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: it was reported that during a tha it was tried to remove the plug covers of a polarcup shell ti-plasma/ha 57 non-cem (75100443), in the direction that was indicated on the plug cover.However, the plug got stuck and could be removed.The procedure was completed without delay using a s+n back-up device.The device used in treatment was returned for investigation.The reported issue could be confirmed upon visual inspection.The left plug is stuck with the polarcup.The right plug was removed.The hexagon head of the jammed plug is observed to be heavily damaged, indicating that high torque was applied.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.The performed investigations confirmed the reported failure mode.The relationship between the reported event and the device was confirmed.There is no indication that the device failed to match specification 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.The returned device will be retained.

• Brand Name: POLARCUP SHELL TI-PLASMA/HA 57 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: 11814101
• Report Number: 9613369-2021-00209
• Device Sequence Number: 3223531
• Product Code: LPH
• UDI-Device Identifier: 07611996118346
• UDI-Public: 07611996118346
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 06/22/2021

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: 75100443
• Device Catalogue Number: 75100443
• Device Lot Number: B2004313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1