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 Material Fragmentation (1261); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333); Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/23/2017

Event Type  Injury  

Event Description

It was reported that a left hip revision was performed due to severe pain; decreased mobility; shedding of metal debris into the bloodstream; tissue damage; and elevated cobalt and chromium levels.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the cup 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 bhr cup and 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.The available medical documents were reviewed.It should be noted the surgical technique indicates the acetabular component should be impacted with 20° of anteversion.The reported pain, elevated metal ions and intraoperative and pathological findings of corrosion and alval may be consistent with findings associated with metal debris; however, the significant anteversion and insufficient abduction of the acetabular cup cannot be ruled out as contributing factors to the elevated metal ions, corrosion and alval.The root cause of the reported clinical reactions cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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: 9908389
• MDR Text Key: 185893278
• Report Number: 3005975929-2020-00095
• 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,Followup
• Report Date: 01/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2011
• Device Catalogue Number: 74120156
• Device Lot Number: 61708
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: 74121150 RESURFACING FEM HEAD 50MM 61726.
• Patient Outcome(s): Hospitalization; Required Intervention