MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 28 XS/-3; PROSTHESIS, HIP, SEMI-CONS, METAL/CERAMIC/POLYMER, CEME OR NON-POROUS, UNCEM

Model Number	75100843
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr, the tabs of an unidentified trial femoral head broke off.It is unknown if any piece fell off inside of the patient.It is also unknown how surgery was completed and for long it was prolonged, if any.Patient was not stated to be harmed.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
T was reported that, during a thr, the tabs of an unidentified trial femoral head broke off.It is unknown if any piece fell off inside of the patient.It is also unknown how surgery was completed and for long it was prolonged, if any.Patient was not stated to be harmed.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.No batch number was communicated so the document history review was not possible.A complaint history review was performed.The occurrence of the reported failure mode is anticipated with a low 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.Based on the information provided to the complaint, it is not possible to confirm the reported failure mode.A relationship between the reported event and the device cannot be confirmed and the root cause of the reported issue remains undetermined.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.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.There is no need for corrective action because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip replacement, the tabs of an unidentified trial femoral head broke off.It is unknown if any piece fell off inside of the patient.It is also unknown how surgery was completed and for long it was prolonged, if any.Patient was not stated to be harmed.The complaint device intended for use in treatment was returned for investigation.A visual evaluation of the returned device was conducted, and it was concluded that one of the four flaps is broken off and this flap was not returned for evaluation.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed no additional complaints reported for the same batch, and one additional similar complaint for the same product number over the past 12 months with similar failure mode.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might break off.These failure modes may further be exacerbated by excessive use of the device over time.The performance of the device is still within the risks level that are anticipated in the risk management documentation.The current design will be further monitored through post-market surveillance processes.No further actions are necessary at this time point.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.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.The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be discarded.

• Brand Name: TRIAL FEMORAL HEAD 28 XS/-3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONS, METAL/CERAMIC/POLYMER, CEME OR NON-POROUS, UNCEM
• 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: 15498400
• Report Number: 9613369-2022-00518
• Device Sequence Number: 5843556
• Product Code: LZO
• UDI-Device Identifier: 07611996121766
• UDI-Public: 07611996121766
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2023
• 2 Devices were Involved in the Event: 1 2

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: 75100843
• Device Catalogue Number: 75100843
• Device Lot Number: A65855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 02/15/2023
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 10/25/2022; 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown