MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Toxicity (2333); No Code Available (3191)

Event Date 12/11/2018

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to metallosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision the bhr cup, hemi head and modular sleeve were removed.The anthology stem was retained.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 patient had bilateral revision surgery and the left revision was performed almost 10½years post implantation, secondary to pain and metallosis.The operative notes documented; ¿we encountered thick fibrous metallosis reaction with fibrinous material and complete bone loss to contained lesions superiorly and posterior-superiorly.¿ it has been reported that the patient is doing very well, and the impact beyond the surgeries cannot be determined.In conclusion, the clinical information provided for both of the hips, of the elevated metal ion levels and the grayish in debris with thick fibrous metallosis reaction, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of 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.Additional information: patient identifier, device identification and device manufacture date.

• Brand Name: BHR ACETABULAR CUP 56MM
• 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: 8247463
• MDR Text Key: 133038672
• Report Number: 3005975929-2019-00015
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• 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
• Report Date: 12/18/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: 74120156
• Device Lot Number: 081880
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 12/18/2019
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71356007, LOT # 08BM20425.; HEMI HEAD, # 74122550, LOT # 07MW15137.; MODULAR SLEEVE, # 74222300, LOT # 08BW15659.; FEMORAL STEM, # 71356007, LOT # 08BM20425; HEMI HEAD, # 74122550, LOT # 07MW15137; MODULAR SLEEVE, # 74222300, LOT # 08BW15659
• Patient Outcome(s): Hospitalization; Required Intervention