MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 46MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120146

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); Toxicity (2333)

Event Date 12/06/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Left hip revision surgery was reportedly performed due to pain, metallosis, toxic levels of metal debris and other complications.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain, metallosis, toxic levels of metal debris and other complications.During the revision the bhr head and bhr cup were removed.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.This legal case has re-opened due to the receipt of medical documents i.E.Chart sticks, primary and revision operative reports.It was reported four years post implantation of a lbhr this (b)(6) female underwent a revision due to pain, metallosis, toxic levels of metal debris and other complications.Intra-operative findings; "the surgeon chose the anterior approach.Once the surgeon entered through the anterior joint capsule metallosis was identified in the region.The surgeon performed an excision of rnetallosis, capsular convert to newer component.Also, the birmingham system does not allow for conversion out of a metal on metal situation.Once the surgeon re-x-rayed the left hip he realized there was an ischium fracture.Additionally, there was sclerosis in the central portion of the femoral canal from the old stem of the birmingham hip." based on the limited clinical information provided the findings are consistent with reactions from metal debris.However, the source cannot be confirmed, neither the pathology report, explant, nor the metal ion levels were provided.Therefore it cannot be concluded whether the reported clinical reactions are associated the implant.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.

• Brand Name: ACETLR CUP HAP 46MM 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: 6383331
• MDR Text Key: 69205442
• Report Number: 3005975929-2017-00054
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2011
• Device Catalogue Number: 74120146
• Device Lot Number: 67428
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2017
• Patient Sequence Number: 1
• Treatment: 4121138/RESURFACING FEMORAL HEAD 38MM/67375; FEMORAL HEAD, # 74121146, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR