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

Catalog Number 74120156

Device Problems Positioning Problem (3009); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

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

Event Date 08/10/2017

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed secondary to elevated metal ions, increasing hip pain, and an unsatisfactory position of the acetabular cup.Fluid consistent with an adverse metal reaction and osteolysis were encountered during surgery.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the acetabular cup, hemi head & modular sleeve were removed.The stem remained implanted.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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.Intraoperatively, fluid consistent with an adverse metal reaction and osteolysis was encountered.The reported intraoperative findings of elevated metal ion levels, fluid, and corrosion may be consistent with findings associated with metal debris.The root cause of the reported clinical symptoms cannot be confirmed.However, the patient¿s comorbidities, past pelvic fractures and history of radiation and multiple steroid injections post tha, cannot be excluded as a contributing factors which could affect bone quality and positioning, high doses of corticosteroids are contraindicated with the use of bhr devices.The patient impact beyond the revision and associated pain cannot be determined.Further, it cannot be concluded that the reported clinical reactions were associated with a malperformance 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: concomitant medical products.

• 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: 9217409
• MDR Text Key: 163117050
• Report Number: 3005975929-2019-00380
• 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
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120156
• Device Lot Number: 69810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2019
• Patient Sequence Number: 1
• Treatment: ACETLR CUP 74120156/ 69810; ANTHOLOGY STEM 71356106/ 05MM05047; HEMI HEAD, # 74122550, LOT # 10303; MODULAR SLEEVE, # 74222300, LOT # 9766; HEMI HEAD, # 74122550, LOT # 10303; MODULAR SLEEVE, # 74222300, LOT # 9766
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR