MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 60MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120160

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333); Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/18/2017

Event Type  Injury  

Event Description

It was reported a left hip revision due to severe pain; decreased mobility; shedding of metal debris into the bloodstream; tissue damage; and elevated cobalt and chromium levels.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr cup and bhr head were removed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup and bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the bhr head.Similar complaints have been identified for the bhr cup.This will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.Based on the limited information provided, the reported pain, limp and elevated cocr levels, and the intraoperative findings of metallosis and discolored tissue may be consistent with findings associated with metal debris.The lateral positioning of the acetabular component cannot be excluded as a result of the reported clinical symptoms and short external rotators which were noted intraoperatively to be completely destroyed.Without supporting post-primary and pre-revision radiographic images, lab reports and/or the analysis of the explanted components, the source of the reported findings cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and expected postoperative healing/pain cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

New information: g4, d4.

• Brand Name: ACETLR CUP HAP 60MM W/ IMPTR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9528620
• MDR Text Key: 172996261
• Report Number: 3005975929-2019-00447
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2012
• Device Catalogue Number: 74120160
• Device Lot Number: 078534
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121154 RESURF FEM HEAD 54MM 082022.
• Patient Outcome(s): Hospitalization; Required Intervention