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 Connection Problem (2900)

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

Event Date 04/17/2020

Event Type  Injury  

Event Description

It was reported that during a unilateral total hip arthroplasty, the 32mm 54-56 linear couldn't be implanted into the 54mm outer cup after several times.It didn't work even after cleaning up the peripheral tissue out of the outer cup and put in cold water.Finally a 55 bone cement cup was used to complete the surgery.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has some signs of damage from the attempted insertion.The device was manufactured in 2019.The medical investigation concluded that, based on the information provided and the product evaluation, the exact root cause could not be determined with confidence.The patient impact beyond the failed attempts of the liner implantation and subsequent 30+ minute surgical extension and change in shell size could not be determined; however, no patient injury was reported.No further medical assessment can be rendered at this time.A dimensional inspection was attempted but the device was too damaged from attempted use to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documentation revealed this failure mode was previously identified.Some potential probable causes for this event could include a fit/sizing issue or an improper surgical technique.Based on this investigation, the need for corrective action is not indicated.Should 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 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: 10059555
• MDR Text Key: 191077153
• Report Number: 1020279-2020-01736
• 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: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• 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: 19DM27915
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 65