MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 S/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED

Model Number	75100856
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, a trial femoral head 36 s/+0 was broken.Surgery was finished with the same device, without any surgical delay.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
It was reported that, a trial femoral head 36 s/+0 was broken.The device, used in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed.The device shows heavy signs of use such as dents and scratches on the outer surface.Furthermore, a small piece broke off at the distal rim.This piece was not returned for investigation.The fragment may have been removed with a forceps.Based on the performed complaint history review, three additional complaints for the batch in scope with the same or similar failure mode were reported so far.A review of the production documentation for the batch in scope did not reveal any deviation from the standard operating procedure which could have contributed to the reported failure mode.A review of the risk management documentation verifies the failure mode and severity of the reported issue.None of any prior escalation actions are related to the reported issue.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Based on the performed investigations, the relationship between the reported event and the device was confirmed and the probable cause for the damaged device is attributed to a wear and tear issue through repeated use over time.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag", all devices must be inspected and controlled for proper functioning after cleaning/disinfection.To date, no further actions are deemed necessary.Smith and nephew will continue to monitor the device for similar issues.Should additional information become available, this complaint will be reassessed.The returned device will be discarded.
Event or Problem Description
It was reported that, a trial femoral head 36 s/+0 was found broken.The head trial came off the neck into the patient when dislocating the hip.The dr had to take a cocher to remove the head in which damaged the head.Surgery was finished with the same device, without any surgical delay.Patient was not injured as consequence of this problem.

• Brand Name: TRIAL FEMORAL HEAD 36 S/+0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12795599
• Report Number: 9613369-2021-00398
• Device Sequence Number: 5271404
• Product Code: LZO
• UDI-Device Identifier: 07611996121896
• UDI-Public: 07611996121896
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,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: 75100856
• Device Catalogue Number: 75100856
• Device Lot Number: A56096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• 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