MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREADED HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71336500

Device Problem Fitting Problem (2183)

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

Event Date 04/22/2021

Event Type  malfunction  

Event Description

It was reported that during a thr surgery the ref threaded hole cover which are used with the reflection 0-hole uncemented cups did not stop when it was screwed into the hole in the bottom of the cup.The reflection threaded central hole cover didn't go all the way through the shell and are still attached.It is unknown if there was a surgical delay, it was completed using the same device.No patient injuries and no other complications were reported.

Manufacturer Narrative

D4, h6.The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.We consider this investigation closed.

• Brand Name: REF THREADED HOLE COVER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11816871
• MDR Text Key: 250358605
• Report Number: 1020279-2021-04150
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010197634
• UDI-Public: 03596010197634
• Combination Product (y/n): N
• PMA/PMN Number: K920430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

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: 71336500
• Device Catalogue Number: 71336500
• Device Lot Number: 21AM15769
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1