MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Swelling (2091); Joint Dislocation (2374); No Code Available (3191)

Event Date 03/31/2016

Event Type  Injury  

Event Description

It was reported that patient underwent left hip revision surgery due to pain, inflammation/swelling, infection, dislocation, hypertrophy and necrosis, elevated chromium and cobalt levels and metallosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain, inflammation/swelling, infection, dislocation, hypertrophy and necrosis, elevated chromium and cobalt levels and metallosis.During the revision the bhr head was removed, the bhr cup remains 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 us legal case was re-opened due to the receipt of medical documents.It was reported eight years post-implantation of a left hip revision surgery due to pain, inflammation/swelling, infection, dislocation, hypertrophy and necrosis,elevated chromium and cobalt levels and metallosis.The explant, was not provided for inclusion in this investigation.According to the revision operative report, "it was evident that there was a significant reaction to the metal with discoloration, hypertrophy and necrosis of the synovial lining.Copious amounts of fluids was seen and the muscle damage was minimal.Once a clear view of the acetabulum was possible.The component was not visually damaged or scratched and was appropriately verted and oriented and solidly fixed."the corresponding laboratory findings for the cobalt and chromium levels were not provided.The reported intraoperative findings of discoloration, hypertrophy and necrosis of the synovial lining are consistent with an adverse reaction to metal debris.However, without the images, the explanted device and metal ion levels, the root cause cannot be concluded.The impact to the patient beyond the revision cannot be concluded.It was also noted that use of a competitor's (stryker) dual mobility liner, femoral head and stem devices were implanted with the bhr cup at the time of revision.This activity was performe 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.

Event Description

Bilateral patient.It was reported that, after a left bhr on (b)(6) 2008 plaintiff has experienced pain and metallosis.Plaintiff underwent a revision surgery on (b)(6) 2016.Plaintiff outcome is unknown.

Event Description

It was reported that, after a thr on (b)(6) 2008, a revision surgery was performed on (b)(6)2016 to revise the left hip due to pain, inflammation/swelling, infection, dislocation, hypertrophy and necrosis, elevated chromium, and cobalt levels and metallosis.The current health status of patient is unknown.

• Brand Name: RESURFACING FEMORAL HEAD 46MM
• 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 05001 ; SZ 05001
• MDR Report Key: 7137534
• MDR Text Key: 95465267
• Report Number: 3005975929-2017-00469
• 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,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 74121146
• Device Lot Number: 080076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2007
• 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: 74120152/ACETLR CUP HAP 52MM W/ IMPTR/086059; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male