MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 XS/-3; PROSTHESIS, HIP, SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTEDORNON-POROUS

Model Number	75100855
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr, a trial femoral head 36 xs/-3 broke.At this time, it is unknown if pieces fell into the patient.Surgery was resumed, with a s+n backup device.It is unknown if a delay happened.The patient was not harmed as a consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
It was reported that, during a total hip replacement, a trial femoral head 36 xs/-3 broke.At this time, it is unknown if pieces fell into the patient.Surgery was resumed, with a s+n backup device.It is unknown if a delay happened.The patient was not harmed as a consequence of this problem.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.So, the mentioned failure mode cannot be confirmed.No batch number was communicated so the document history review was not possible.A complaint history review was performed on product number, revealing 5 additional complaints with similar failure mode.No adverse trends were found for this event.Due to insufficient information it is not possible to perform a review of past corrective actions.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.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, the performed investigation do not lead to an accurately determined cause.Based on the available information it is not possible to investigate whether the reported device met 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" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.There is no need for further actions 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, a trial femoral head 36 xs/-3 broke.The patient was not harmed as a consequence of this problem.The complaint device used in treatment was returned for investigation.A visual evaluation of the device was conducted, and it was concluded that one of the four flaps of the trial is cracked, however there is no piece missing.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 2 additional complaints reported for the same batch, and 7 additional similar complaints for the same product number over the past 12 months with similar failure mode.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.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause of the event can be attributed to problems traced to design features of the device that do not support or interfere with the intended purpose of the device.Additionally, repeated steam sterilization processes could contribute to an embrittlement.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), 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 36 XS/-3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTEDORNON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau, ch-5000 ; SZ
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau, ch-5000 ; SZ
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15895232
• Report Number: 9613369-2022-00603
• Device Sequence Number: 12460811
• Product Code: LZO
• UDI-Device Identifier: 07611996121889
• UDI-Public: 07611996121889
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/13/2023

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: A59038
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 12/07/2022; 03/09/2023; 03/09/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/09/2022; 03/13/2023; 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2016
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown