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

Model Number 74120152

Device Problems Connection Problem (2900); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 08/04/2015

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain and discomfort.Surgeon's revision notes reportedly stated metal debris and grossly loose femoral head.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain and discomfort.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.This patient was implanted with a right bhr (b)(6) due to avn.It is reported that the patient presented for a routine follow-up ~ 6 years post implantation, and although he had absolutely no symptoms, the femoral neck was found to be collapsed on the right side, and his metal ions were excessively high, thus a revision was performed.It was also noted in the report that the patient had small implants that could be implicated in subplanar wear.It was further indicated that an mri was obtained, which failed to demonstrate any pseudotumors; additionally, there was no metallosis in the abductor tissues and they appeared normal; however, there is some metallosis of the synovium around the hip itself.Upon dislocation of the hip, it was noted that the femoral component was grossly loose and came off by hand, and the femoral head and neck were markedly atrophied; the acetabular component was still secure.Neither supporting intra-op findings/images nor pathology/lab results were provided to confirm the reported elevated cobalt and chromium levels.The clinical symptoms of the reported elevated cobalt/chrome levels, the report of metallosis of the synovium, and loosening of the femoral component may be consistent with an adverse reaction to metal debris, but this cannot be confirmed based on the information provided.The source of the reported elevated metal ions cannot be determined; however the relationship to the previous avn cannot be ruled out.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

Bilateral patient.It was reported that right hip revision surgery was performed due to elevated metal ion levels, femoral head and neck collapsed on the right-side with loose femoral head, pain, and discomfort.

• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6515177
• MDR Text Key: 73448120
• Report Number: 3005975929-2017-00077
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• 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,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: 74120152
• Device Catalogue Number: 74120152
• Device Lot Number: 088306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74121146,
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male