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 Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 01/27/2015

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on right hip due to popping, grinding, pain, metallosis and pseudotumor.

Manufacturer Narrative

It was reported that a revision surgery was performed on right hip due to popping, grinding, pain, metallosis and pseudotumor.During the revision the bhr head and bhr cup were removed.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.According to the provided revision report, the patient had pain, not significantly elevated blood metal ions and a no preoperative signs of infection.During the revision straw-colored fluid without purulence and a well ingrown cup in 40° anteversion was noted.Review of the provided implantation report did not reveal any inconsistencies related to the surgical technique that could explain the later revision.No details about the implant position was provided.Without the device available it remains unclear whether the anteversion of the cup led to an increased amount of wear.The reason for the anteversion remains also unclear.The nature of the fluid and the reason for the pain and what caused them remains also unclear.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: 7613791
• MDR Text Key: 111475597
• Report Number: 3005975929-2018-00217
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 74120156
• Device Lot Number: 084769
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121150/RESURFACING FEMORAL HEAD 50MM/082287; BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.; BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 58 YR