MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71336454

Device Problem Fitting Problem (2183)

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

Event Date 09/11/2018

Event Type  malfunction  

Event Description

It was reported that the reflection microstable locking mechanism liner failed to lock inside with the reflection cup during a total hip replacement procedure.The surgeon found it difficult once dislocation was done with the original polar prosthesis.The surgeon could not fix the liner since it was not locking properly.Almost one hour twenty minutes was spent on the table, the implants were removed.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.A visual inspection of the returned liner indicated damage to the liner lip, with damage to the porous coating of the shell, and the screws showed some damage to the threads and hex feature.A dimensional evaluation of the liner indicated surface damage noted on the face of the liner.Damage was also noted to the porous coating of the shell and to the id of the shell, especially around the gage point of the screw holes.For the shell, minor deviations were noted on the spherical radius of the id and the profiles of the holes at gage point, which were consistent with the observed damage from attempted use.Minor deviations were also noted on the profile of the splines.For the liner, the profile of splines at gage point measured oversize on cmm, and the profile of locking detail also failed overlay inspection.All other checks measured in specification for both parts.Functionally, it was possible to lock the liner into the shell with considerable force.A dimensional evaluation of the screws could not verify failure mode as the returned screws function as intended per inspection methods.All relevant dimensions are within drawing tolerances.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 on the listed parts revealed prior complaints for the listed batches.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: REF THREE HOLE SHELL 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 7931824
• MDR Text Key: 122629866
• Report Number: 1020279-2018-02042
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• PMA/PMN Number: K960094
• 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: 03/19/2019

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 Catalogue Number: 71336454
• Device Lot Number: 17KM15756
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 09/11/2018
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71332525 / 18BM04459; 71332530 / 18BM04456
• Patient Outcome(s): Other; Required Intervention