MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 36 +8; PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICPOLYMER,CEMENTEDORNON-POROUS

Model Number	75100858
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a trial femoral head 36 l/+8 has cracked and broken sections.As this was noticed in a non-surgical environment, there was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Additional Manufacturer Narrative
(b)(4).D1: brand name updated.D4: catalog number and udi updated.
Additional Manufacturer Narrative
Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is cracked and gouged rendering the device inoperative.A review of complaint history revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: MI TRIAL FEM HEAD 36 +8
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICPOLYMER,CEMENTEDORNON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; brooks road 1450; memphis TN 38116
• 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: 12924302
• Report Number: 9613369-2021-00419
• Device Sequence Number: 5737333
• Product Code: LZO
• UDI-Device Identifier: 07611996121919
• UDI-Public: 07611996121919
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2022

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: 75100858
• Device Catalogue Number: 71369723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 11/16/2021; 02/07/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/18/2022; 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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