MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/49; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75023359
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a thr surgery, a polarcup trial insert nav 22/49 broke off outside of the wound after being used.Surgery had been completed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a thr surgery, a polarcup trial insert nav 22/49 (article no.75023359 / lot number a75251) broke off outside of the wound after being used.Surgery had been completed, without any delay, with the same device.Patient was not harmed as consequence of this problem.The complaint device, intended for use in treatment, was returned for investigation.The production documentation was reviewed.No deviations from the standard operating procedure were found.The complaint history review was performed, no further complaints for devices of the same lot were found.The risk management review was performed, 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 performed investigations, the reported failure mode could be confirmed.A relationship between the reported event and the device can be confirmed.The reported device met 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.This version of the device will be monitored for similar issues.This investigation is considered closed.The complaint device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT NAV 22/49
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12681104
• Report Number: 9613369-2021-00389
• Device Sequence Number: 3991285
• Product Code: LPH
• UDI-Device Identifier: 07611996112481
• UDI-Public: 07611996112481
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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: 75023359
• Device Catalogue Number: 75023359
• Device Lot Number: A75251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown