MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

Device Problems Naturally Worn (2988); Migration (4003)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Reaction (2414); Ambulation Difficulties (2544)

Event Date 06/24/2014

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to progressive pain, difficulty walking, elevated cobalt levels from failed right hip resurfacing arthroplasty consistent with metal-on-metal wear.Surgical findings confirmed that the failed birmingham right hip resurfacing arthroplasty resulted from metal-on-metal wear and a resulting adverse metal reaction to metal wear debris.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr cup was removed.The bhr head remained implanted.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 bhr cup and bhr head 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 and no further actions are required at this time.The available medical documents were reviewed.The reported adverse reaction to metal wear debris and the intraoperative findings of migration and the acetabular component into anteversion and high inclination as well as bone loss may be consistent with findings associated with metal debris.The changes in position of the acetabular component could accelerate wear and lead to metal debris and result in metallosis as well.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant versus variation of the initial implant orientation as it is unknown if the revision findings of acetabular implant position was due to migration or present since implantation.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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: ACETLR CUP HAP 56MM 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
• MDR Report Key: 8914436
• MDR Text Key: 155002852
• Report Number: 3005975929-2019-00296
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 74120156
• Device Lot Number: 077732
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 08/17/2019; 08/18/2020
• Supplement Dates FDA Received: 04/05/2020; 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121150 RESURFACING FEM HEAD 50MM L# 077632; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention