MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 S/+0; PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT

Model Number 75100856

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that three trial femoral head 32 l/+8 were found broken.It is not known if all events are related to the same procedure.No injuries or surgical delays reported.

Event Description

It was reported that three trial femoral head 36 s/+0 were found broken.It is not known if all events are related to the same procedure.No injuries or surgical delays reported.

Manufacturer Narrative

Corrected data in b5.

Manufacturer Narrative

Upon receipt of additional information it has been determined that this report is a duplicate of mdr 9613369-2020-00270 and should therefore be disregarded.

Manufacturer Narrative

Investigation results: it was reported that three trial femoral head 36 s/+0 were found broken.It is not known if all events are related to the same procedure.No injuries or surgical delays were reported.The devices, intended for use in treatment, were not returned for investigation and no batch number was communicated.The reported failure can therefore not be evaluated.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 devices or additional information become available, this investigation will be reopened.Smith and nephew will continue to monitor the device for similar issues.This investigation is considered closed.

• Brand Name: TRIAL FEMORAL HEAD 36 S/+0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11061094
• MDR Text Key: 223377651
• Report Number: 9613369-2020-00271
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/19/2021

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
• Device Operator: Health Professional
• Device Model Number: 75100856
• Device Catalogue Number: 75100856
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/09/2020; 02/26/2021; 03/16/2021
• Supplement Dates FDA Received: 12/27/2020; 03/04/2021; 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1