MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIAL FEMORAL HEAD 40 XS/-4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100868
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that, during a thr surgery, one trial femoral head 40 xs/-4 broke.No pieces fell into the patient.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was broken into multiple pieces, rendering the device inoperative.It is undetermined if all the pieces were returned.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed 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.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.
Additional Manufacturer Narrative
H11.Corrected information in d3 and g1 (manufacturing site name and address).Internal reference number: (b)(4).

• Brand Name: TRIAL FEMORAL HEAD 40 XS/-4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12599690
• Report Number: 9613369-2021-00383
• Device Sequence Number: 17211141
• Product Code: LZO
• UDI-Device Identifier: 07611996122015
• UDI-Public: 07611996122015
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2022

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: 75100868
• Device Catalogue Number: 71366516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 10/28/2021; 04/26/2022
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/02/2021; 04/26/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown