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
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient undergone revision thr surgery for recurrent dislocation.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2018-02354
• Device Sequence Number: 11121634
• Product Code: MEH
• UDI-Device Identifier: 03596010452801
• UDI-Public: 03596010452801
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2011
• Device Catalogue Number: 71334252
• Device Lot Number: 01BM13433A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/03/2018
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention