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

Catalog Number 74120152

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problems Pain (1994); Toxicity (2333); Ambulation Difficulties (2544); Test Result (2695)

Event Date 03/06/2018

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to constant pain, difficulty walking and elevated chromium and cobalt levels from failed right hip resurfacing arthroplasty consistent with metal-on-metal wear.Dr.(b)(6)'s surgical findings from the (b)(6) 2018 procedure included a copious amount of fluid consistent with a pseudo tumor caused by plaintiff's bhr metal-on-metal articulation and necrotic bone.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr rup and head were removed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the head and cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.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 the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed.The reason for the revision was reported as the infection.Although it was reported that the chromium and cobalt levels were elevated, neither the levels nor the lab reports were provided.It should be noted that a severely overweight patient is a contraindication of bhr use, and, based on literature reports and post-market data, obesity was identified as a risk factor for early revision.The reported pseudotumor and elevated chromium and cobalt levels are consistent with findings associated with metal debris; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain, elevated cobalt and chromium levels, infection, and pseudotumor cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Due to the reported leg length discrepancy, there is a potential for continued hip pain, issues with gait and/or functional impairment.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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 7873105
• MDR Text Key: 120152004
• Report Number: 3005975929-2018-00312
• 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: other
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2012
• Device Catalogue Number: 74120152
• Device Lot Number: 75618
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.; HEAD 74121146, LOT 74629.; BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR