MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABLR CUP HAP 44MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121142

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Weakness (2145); Injury (2348); No Code Available (3191)

Event Date 12/14/2015

Event Type  Injury  

Event Description

Us legal claim: it was reported the customer experienced pain, weakness in legs and hips, elevated cocr levels, fluid accumulations and revision surgery has been performed.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain, weakness in legs and hips, elevated cocr levels, fluid accumulations.The bhr head was removed during surgery, however bhr cup 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.The available medical documents were reviewed.This patient underwent a left bhr revision 8 years post implantation, due to reported pain and elevated cobalt and chromium levels.The revision op report indicates that intraoperatively, there was a significant amount of clear fluid throughout the joint, as well as some necrotic tissue forming a pseudocapsule, but minimal metallosis.It was also noted that the acetabular component was well fixed, well positioned and the metal articulation found to be extremely pristine with no significant evidence of metallosis, scratching or other wear.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 pain and elevated cobalt and chromium levels 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 cobalt and chromium levels cannot be determined.However patient's history ehlers danlos syndrome cannot be excluded as a contributing factor of the reported pain.The future impact to the patient beyond the revision cannot be concluded.It was also noted that a competitor's femoral stem, femoral head and dual mobility liner (which were all stryker products) were implanted at the time of revision, alongside the remaining bhr cup.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information, "do not mix components from other manufacturers." 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 ACETABLR CUP HAP 44MM W/ IMPTR
• 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: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6173042
• MDR Text Key: 62319664
• Report Number: 3005975929-2016-00063
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: 74121142
• Device Lot Number: 080879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2007
• 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: 74120150, ACETLRCUP HAP 50MM W/IMPTR, 080947
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female