MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP T-HANDLE UNIDIRECTIONAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75023347
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during thr surgery, the edges of the polarcup t-handle unidirectional worn out while unplugged.No significant delays were reported and the procedure was finished by changing the surgical technique.No patient was harmed.
Additional Manufacturer Narrative
It was reported that, during thr surgery, the edges of the polarcup t-handle unidirectional worn out while unplugged.No significant delays were reported and the procedure was finished by changing the surgical technique.No patient was harmed.The complaint device, used in treatment, was not returned for investigation.Pictures of the complaint device were provided, based on these pictures, the tip of the instrument showed slight signs of wear however this cannot be confirmed conclusively without the instrument and it is unclear if the instrument is still functional.The production documentation was reviewed, no deviations from the standard manufacturing procedure were found.The complaint history review was performed.No further complaints were found for devices of the same lot number.The severity and the failure mode are covered through our risk management.The ifu (lit.No.12.23 ed 05/16) requires "before use, the functionality of surgical instruments should be checked." all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on the limited information provided, the medical assessment could not be performed.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.No probable cause can be determined.Normal wear and tear through repeated 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.No further actions are deemed necessary.Should additional information become available, this complaint will be reassessed.This version of the device will be monitored for similar issues.This investigation is considered closed.

• Brand Name: POLARCUP T-HANDLE UNIDIRECTIONAL
• 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: 11843366
• Report Number: 9613369-2021-00227
• Device Sequence Number: 4545415
• Product Code: JDI
• UDI-Device Identifier: 07611996112368
• UDI-Public: 07611996112368
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: 75023347
• Device Catalogue Number: 75023347
• Device Lot Number: B67652
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 80