MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF NH HA SHELL SZ 52MM; PRSTHSS,HP,SM-CNSTRND,UNCMNTD,MTL/POLYMER,NON-POROUS,CALICUM-PHOSPHATE

Catalog Number 71334252

Device Problem Unintended Movement (3026)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 10/22/2018

Event Type  Injury  

Event Description

It was reported that patient undergone revision thr surgery for recurrent dislocation.

Manufacturer Narrative

The associated reflection xlpe acetabular liner was not returned for evaluation.The device was manufactured in 2002.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.A clinical evaluation noted that undated x-ray photos were provided and reviewed, and show a steep inclination of the shell but doesn¿t appear to have signs of loosening, however no prior images were provided to assess whether this has migrated over time, and therefore contributed to the reported dislocations.The original implantation x-rays were not provided for comparison.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation the cause of the reported multiple dislocations may possibly be attributed to the position of the acetabular shell.It can¿t be confirmed if the position has changed over time to now be an issue, or if the patient¿s age and possible age of the liner was a contributing factor.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: REF NH HA SHELL SZ 52MM
• Type of Device: PRSTHSS,HP,SM-CNSTRND,UNCMNTD,MTL/POLYMER,NON-POROUS,CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8036165
• MDR Text Key: 126061298
• Report Number: 1020279-2018-02354
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010452801
• UDI-Public: 03596010452801
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2011
• Device Catalogue Number: 71334252
• Device Lot Number: 01BM13433A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 92 YR