MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 M/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100857
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka a trial femoral head 36 m/+4 was broken.Surgery was finished with a smith and nephew back up device, without any surgical delay.Patient was not injures as consequence of this problem.
Additional Manufacturer Narrative
It was reported that, during a tka a trial femoral head 36 m/+4 was broken.Surgery was finished with a smith and nephew back up device, without any surgical delay.Patient was not injures as consequence of this problem.The device, intended for use in treatment, was not returned for investigation.The batch number was not communicated and is unknown.A product evaluation could therefore not be performed.A batch related complaint history review could not be performed.A complaint history review using post market data was performed.This complaint is in line with the result of this data.A relationship between the reported event and the device cannot be confirmed.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.Based on the available information, a thorough investigation cannot be conducted and the root cause of the reported issue remains undetermined.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.No further actions have been initiated.If the reported device or additional information become available, this investigation will be reopened.

• Brand Name: TRIAL FEMORAL HEAD 36 M/+4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 12267515
• Report Number: 9613369-2021-00338
• Device Sequence Number: 5062248
• Product Code: LZO
• UDI-Device Identifier: 07611996121902
• UDI-Public: 07611996121902
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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): 10/06/2021

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: 75100857
• Device Catalogue Number: 75100857
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1