MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 M/+4; PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICPOLYMER,CEMENTEDORNON-POROUS

Model Number	75100857
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr, the inside of a trial femoral head 36 m/+4 broke.Additionally, no pieces fell into the patient.Surgery was resumed, without any delay, with a backup device.The patient was not harmed as a consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip replacement, the inside of a trial femoral head 36 m/+4 broke.The patient was not harmed as a consequence of this problem.The complaint device intended for use in treatment was not completely returned for investigation.A visual evaluation of the returned device was conducted, and it showed that one flap is broken.The broken flap was not returned.In general, the device shows heavy signs of use such as gouges, cracks and scratches.It was concluded that the complaint device was fractured.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.No additional complaints for the affected batch nor additional complaints for the same product number were found during a complaint history review.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.The root cause of this device failure may arise from problems traced to design features that do not interfere with the intended purpose of the device.Normal wear and tear are known to contribute to the reported event.Additionally, repeated steam sterilization processes could contribute to an embrittlement.There is no objective indication that the reported devices failed to meet manufacturing specifications upon release for distribution.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.No further actions are necessary at this time point.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be discarded.

• Brand Name: TRIAL FEMORAL HEAD 36 M/+4
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICPOLYMER,CEMENTEDORNON-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: 16048325
• Report Number: 9613369-2022-00606
• Device Sequence Number: 6437133
• Product Code: LZO
• UDI-Device Identifier: 07611996121902
• UDI-Public: 07611996121902
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K132435
• 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): 01/17/2023

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: 75100857
• Device Catalogue Number: 75100857
• Device Lot Number: A64066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/26/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown