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

Model Number 75100856

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 04/21/2021

Event Type  malfunction  

Event Description

It was reported that during a thr, the trial femoral head 36 s/+0 broke outside of the patient.No patient injury was reported.There was no significant delay and the procedure was finished using a smith & nephew back up.

Manufacturer Narrative

H3, h6: it was reported that during a total hip replacement surgery, the trial femoral head 36 s/+0 broke outside the patient.There was no significant delay and the procedure was finished using a smith & nephew back up device.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 review of the production history could not be performed.The reported failure can therefore not be evaluated.A relationship between the reported event and the device cannot be confirmed.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.Based on the available information, a thorough investigation cannot be conducted and the root cause of the reported issue remains undetermined.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.No further actions have been initiated.If the reported device or additional information become available, this investigation will be reopened.

Manufacturer Narrative

D4: lot number and expiration date added.H4: manufacture date added.(b)(4).

Manufacturer Narrative

H3, h6: it was reported that during a total hip replacement surgery, the trial femoral head 36 s/+0 broke outside the patient.The device, intended for use in treatment, was returned for investigation.The relationship between the reported event and the device could be confirmed upon visual inspection.At the distal rim of the device, a part is broken and is missing.The fragment may have been removed with a forceps.Apart from that, the device shows heavy signs of use such as dents and scratches on the outer surface potentially originating from a grasping forceps as well.The connection mechanism of the trial head to the stem cone was checked within a functional evaluation which was passed.A complaint history review was performed.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.Hence, there is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Based on the performed investigations, the probable cause for the damaged/broken device is attributed to a wear and tear issue through repeated use over time.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.To date, no further actions are deemed necessary.Smith and nephew will continue to monitor the device for similar issues.The returned device will be discarded.

Manufacturer Narrative

(b)(4) h6: medical device problem code updated to fracture.

• Brand Name: TRIAL FEMORAL HEAD 36 S/+0
• Type of Device: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11808903
• MDR Text Key: 250414831
• Report Number: 9613369-2021-00203
• 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,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/13/2021

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: A60204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2021
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 06/02/2021; 06/02/2021; 06/02/2021; 08/12/2021
• Supplement Dates FDA Received: 06/03/2021; 07/21/2021; 08/09/2021; 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1