MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 XS/-3; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75100855
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a fin has broken on the inside of the trial femoral head.The event occurred during procedure, while outside the patient.No surgical delay or injury to the patient was reported.
Additional Manufacturer Narrative
It was reported that a fin has broken on the inside of the trial femoral head.The event occurred during procedure, but while outside the patient, so no pieces fell into the patient.The procedure was completed using a smith+nephew backup device.The device, intended for use in treatment, was not returned for investigation.The batch number was not communicated and is unknown.A production history review could therefore not be performed and the reported failure can not be evaluated.A complaint history review was performed.A relationship between 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.No probable cause can be determined.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.The root cause of the reported issue remains undetermined.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 XS/-3
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11617773
• Report Number: 9613369-2021-00144
• Device Sequence Number: 3668192
• Product Code: LZO
• UDI-Device Identifier: 07611996121889
• UDI-Public: 07611996121889
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2021

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: 75100855
• Device Catalogue Number: 75100855
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 07/05/2021; 08/02/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 07/06/2021; 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1