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

Catalog Number 74120152

Device Problem Insufficient Information (3190)

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

Event Date 11/20/2015

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that revision surgery was performed due to metallosis, loosening and elevated metal ion levels.

Manufacturer Narrative

Following the receipt of medical documentation and a legal claim, our previous investigations of this reported left hip bhr revision were reopened.It was reported that revision surgery was performed due to device loosening, elevated test results and metallosis.At the time of revision, both the bhr head and cup were revised.As of today, device return and additional information has been requested for this revision 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 and did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of available medical documents was conducted.According to the provided documents, the patient started having left hand/upper extremity tremor after the implantation.Following, the patient was diagnosed parkinson syndrome with tremor.Approximately 4 years after the implantation the patient had hip pain.Approximately 3 months before the revision pain worsened and a clearly wrong positioned femoral component was observed.This was described as radiologically loosened and varus tilted.The provided x-rays confirm this.All blood metal ion reports that were provided were dated after the revision.2 months after the revision the cobalt blood concentration was 7.1 ¿g/l and chromium concentration was 5.4 ¿g/l.Over the next 4 years, the levels remain roughly between 4.5 and 2 ¿g/l for chromium and roughly between 5 and 1.5 ¿g/l for cobalt.This is associated to the right side resurfacing.According to the revision, there was femoral head necrosis and a massive peri-acetabular osteolysis, a massive bursitis at the trochanter and a clear metallosis.The provided pathology report indicates that the left hip capsule showed a pronounced reaction to foreign body particles.The acetabular cup position was estimated to be approximately 10° beyond the accepted "safe" range of 40°±10°.It remains unclear whether the reported findings correspond to an increased amount of wear on the bearing surfaces, as the devices were not available for analysis.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: BHR ACETABULAR CUP 52MM
• 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: 5242765
• MDR Text Key: 31828703
• Report Number: 3005477969-2015-00303
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2013
• Device Catalogue Number: 74120152
• Device Lot Number: 08BW15528
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74121146, LOT # 082804
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR