MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problem Malposition of Device (2616)

Patient Problems Erosion (1750); Necrosis (1971); Pain (1994); Toxicity (2333); Osteolysis (2377); No Code Available (3191)

Event Date 02/10/2016

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed.Pain, extensive, metallosis, osteolysis, tissue death, erosion of the abductor musculature and rectus femoris, elevated levels of cobalt & chromium, malposition of the acetabular component and pelvic bone loss reported.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain, extensive, metallosis, osteolysis, tissue death, erosion of the abductor musculature and rectus femoris, elevated levels of cobalt & chromium, malposition of the acetabular component and pelvic bone loss reported.During revision the bhr head and the 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.Review of the provided implantation report did not reveal any inconsistencies related to the surgical technique that could explain the later revision.According to the provided revision report, the patient was quite active and started complaining of increasing pain and achiness over the past year before the revision and had elevated blood metal ions.The resurfacing was diagnosed to be unstable, with extensive metallosiss and osteolysis and pelvic bone loss.The acetabular component being mal-positioned.Without x-rays the cup mal-positioning cannot be assessed and it remains unclear whether it was migrated or implanted in this position.A relation to the reported findings is possible.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 52MM 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: 7236653
• MDR Text Key: 98839227
• Report Number: 3005975929-2018-00033
• 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
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• 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: 74857
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0000468636/FINSBURY ORTHO/74629 /; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR