MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122152

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

Patient Problems Failure of Implant (1924); Necrosis (1971); Toxicity (2333); Injury (2348); Osteolysis (2377)

Event Date 11/18/2016

Event Type  Injury  

Event Description

It was reported a right hip revision surgery due to failed metal-on metal right femoral hip with aseptic loosening of acetabular component, metallosis and extensive abductor muscle necrosis and ischial osteolysis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr cup and femoral 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 femoral head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the cup and head.However, as bhr resurfacing systems of this size are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.Bases on information provided, the reported intraoperative findings of metallosis, fluid and necrosis may be consistent with findings associated with metal debris.Of note, the patient is diagnosed with hereditary hemochromatosis.He had not had any therapeutic phlebotomies for about 18 months prior to the revision (from early 2015 through (b)(6)2016).Without supporting post-primary and pre-revision radiographic images, lab/pathology 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 post-operative 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: ACETABULAR CUP HAP SIZE 44/52
• 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: 9528621
• MDR Text Key: 173172163
• Report Number: 3005975929-2019-00448
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74122152
• Device Lot Number: 08FW17304
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/29/2019
• Supplement Dates Manufacturer Received: 06/30/2020; 08/18/2020
• Supplement Dates FDA Received: 07/04/2020; 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74123144 FEM HEAD 44MM 08EW17044.
• Patient Outcome(s): Hospitalization; Required Intervention