MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 M/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100857
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trial broke during surgery, while outside the patient.No pieces fell into the patient.The procedure was completed using a sn backup device.No surgical delay or injury to the patient was reported.
Additional Manufacturer Narrative
H3, h6: it was reported that the trial broke during surgery, while outside the patient.No pieces fell into the patient.The procedure was completed using a sn backup device.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed.The trial ball head fractured in multiple areas.Scratch marks indicate excess mechanical stress applied through pointed tools and/or pliers on the complained device.It is likely that the device could not easily be removed from stem cone during surgery which led to the use of pliers and excess force in the removal of the trial ball head.However, there are no indications of material defects which could have led to the failure.No additional complaint with batch: a60979 was reported so far.A review of the production documentation for the batch in scope did not reveal any deviation from the standard operating procedure.The relationship between the reported event and the device was confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Based on the performed investigation, no probable cause can be determined due to insufficient information provided.Normal wear and tear through repeated is known to contribute to the reported event.No further actions are deemed necessary.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.S+n will continue to monitor these devices for similar issues.The returned device will be retained.This investigation is considered closed.

• Brand Name: TRIAL FEMORAL HEAD 36 M/+4
• 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
• MDR Report Key: 11654379
• Report Number: 9613369-2021-00154
• Device Sequence Number: 17017917
• Product Code: LZO
• UDI-Device Identifier: 07611996121902
• UDI-Public: 07611996121902
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 75100857
• Device Catalogue Number: 75100857
• Device Lot Number: A60979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1