MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121150

Device Problems Naturally Worn (2988); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544); Test Result (2695)

Event Date 08/21/2019

Event Type  Injury  

Event Description

It was reported that a left hip revision surgery was performed due to unexplained pain, difficulty walking, elevated test results, and metal-on-metal wear.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the head and cup 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 head and cup.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable 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.No further actions are required at this time.The medical records were reviewed.Based on the information provided, the reported pain and elevated cocr levels may be consistent with findings associated with metal debris.Without supporting radiographic images, pathology results and/or the analysis of the explanted components, the root cause of the reported clinical symptoms 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 associated post-op 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: RESURFACING FEMORAL HEAD 50MM
• 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: 9309345
• MDR Text Key: 165982971
• Report Number: 3005975929-2019-00399
• 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: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 74121150
• Device Lot Number: 077740
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Patient Sequence Number: 1
• Treatment: 74120156 ACETLR CUP HAP 56MM W/IM 081287
• Patient Outcome(s): Hospitalization; Required Intervention