MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 28 S/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100844
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that the trial femoral head 28 s/+0 broke.As this was noticed after surgery, the patient was no longer involved.
Additional Manufacturer Narrative
H3, h6: it was reported that the trial femoral head 28 s/+0 broke.The device was not returned for investigation and the batch number is unknown.A product evaluation could therefore not be performed.However, a complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Due to insufficient information, it is not possible to perform a review of past corrective actions.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.The root cause for 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 28 S/+0
• 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
• 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: 14580891
• Report Number: 9613369-2022-00268
• Device Sequence Number: 2058103
• Product Code: LZO
• UDI-Device Identifier: 07611996121773
• UDI-Public: 07611996121773
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (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): 06/27/2022

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: 75100844
• Device Catalogue Number: 75100844
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 06/27/2022
• 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