MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122154

Device Problem Device Slipped (1584)

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

Event Date 07/07/2014

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to elevated metal ion levels and loose metal debris.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to elevated metal ion levels and loose metal debris.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.According to the provided revision report, the patient had increasing pain, chromium levels of 1.7 and cobalt of 1.9 (no units provide).Chromium was deemed elevated.Preoperatively there were no signs of infection (aspirate: negative gram stain, esr and crp were normal).During the revision a small amount of amber coloured fluid and metal debris was encountered in the hip, which was related to soft-tissue reaction and an early stage of adverse local tissue reaction to metal-on-metal bearings.Review of the provided implantation and revision report did not reveal any findings that could have contributed to the reported reasons for the revision.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.

Event Description

It was reported that left hip revision surgery was performed on (b)(6) 2014 due to elevated metal ion levels and loose metal debris.Chromium 1.7 & cobalt 1.9 (uom unknown).Small amount of amber color fluid and metal debris noted during revision.Posterior soft tissue had small cavity with thick psuedocapsule.The tissue biopsy report revealed fibrosing inflammation and granulomatous reaction on the tissue around the joint.Patient outcome is unknown.

• Brand Name: ACETABULAR CUP HAP SIZE 48/54
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds
• MDR Report Key: 7482328
• MDR Text Key: 107187164
• Report Number: 3005975929-2018-00145
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 74122154
• Device Lot Number: 12DW37118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/12/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 74123148/FEMORAL HEAD 48MM/12DW37154 /; FEMORAL HEAD, # 74123148, LOT # 12DW37154; FEMORAL HEAD, # 74123148, LOT # 12DW37154
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male