MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 54MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120154

Device Problem Metal Shedding Debris (1804)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 12/16/2013

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to metallosis and elevated cobalt and chromium levels.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

It was reported that right hip revision surgery was performed due metallosis and elevated cobalt and chromium levels.During surgery bhr cup and bhr head 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 discharge and implantation report, the cup was implanted "matching the patient's anteversion and inclination about 45 and 30".According to the surgical technique (2006 usa) the acetabular component should be impacted with 20° of anteversion and 45° opening.According to the provided revision report, there was darkish, black and metal colored fluid within the joint, which was described as typical adverse reaction to metal.There was black stained tissue at the acetabulum, black synovium that was deemed a pseudotumor.There was eroding bone, bone loss and fibrosis at the femoral component and at acetabulum.The bone was deemed sufficient for a new cup.A sub-optimal cup position can lead to an increased amount of wear.Details about the intraoperative findings and about their nature was not provided.No root cause can be determined based on the medical documents.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 54MM 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: 6854413
• MDR Text Key: 85607570
• Report Number: 3005975929-2017-00263
• 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: 08/14/2018

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: 12/31/2011
• Device Catalogue Number: 74120154
• Device Lot Number: 70238
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/11/2017
• Supplement Dates Manufacturer Received: 09/01/2017; 09/01/2017
• Supplement Dates FDA Received: 11/29/2017; 08/14/2018
• Patient Sequence Number: 1
• Treatment: 74121146/RESURFACING FEMORAL HEAD 46MM/77661 /; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR