MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 25MM; PROST, HIP, SEMI-CNSTRAIND UNCEMENTED, MET/POLY, NON-PORS, CALICUM-PHSPHT

Model Number 71332525

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2020

Event Type  Injury  

Event Description

It was reported that after arthroscopy procedure it was noticed that there was a displacement of the acetabular screw.No delay reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed and the displacement was confirmed.The clinical/medical investigation concluded that, the root cause of the reported event could not be definitively concluded.The patient impact beyond the reported screw displacement could not be determined, as it was reported that the shell had the desired press-fit and had no risk of migration.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue, traumatic injury or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REF SPHER HEAD SCREW 25MM
• Type of Device: PROST, HIP, SEMI-CNSTRAIND UNCEMENTED, MET/POLY, NON-PORS, CALICUM-PHSPHT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10788628
• MDR Text Key: 214721806
• Report Number: 1020279-2020-06177
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010460462
• UDI-Public: 03596010460462
• Combination Product (y/n): N
• PMA/PMN Number: K990666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71332525
• Device Catalogue Number: 71332525
• Device Lot Number: 19DM20999
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other