MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 S/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAM/POLYM, CEMENTOR NON-POROUS, UNCE

Model Number 75100856

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a thr surgery one of the flanges of the trial femoral head 36 s/+0 inside the head trial bent while performing a trial reduction.The procedure was completed, without delay, using a s+n back-up device.No patient injuries and no other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: it was reported that during a total hip replacement surgery, one of the flanges of the trial femoral head 36 s/+0 bent while performing a trial reduction.The device, intended for use in treatment, was not returned for investigation.The batch number was not communicated and is unknown.A complaint history review was performed but a production history review could not be performed.Based on the available information, it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.A relationship between the reported event and the device cannot be confirmed.No probable cause can be determined.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.Based on the available information, a thorough investigation cannot be conducted and the root cause of the reported issue remains undetermined.No further actions have been initiated.If the reported device or additional information become available, this investigation will be reopened.

• Brand Name: TRIAL FEMORAL HEAD 36 S/+0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAM/POLYM, CEMENTOR NON-POROUS, UNCE
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11821090
• MDR Text Key: 251236532
• Report Number: 9613369-2021-00213
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996121896
• UDI-Public: 07611996121896
• Combination Product (y/n): N
• PMA/PMN Number: K132435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75100856
• Device Catalogue Number: 75100856
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1