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 Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Toxicity (2333); Arthralgia (2355); Reaction (2414); No Code Available (3191)

Event Date 04/12/2016

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to severe and increasing left hip pain, swelling, severe metal-on-metal reaction with extremely high elevated serum cobalt and chromium levels.Bilateral patient, right hip revision to be reported via subsequent mdr.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to severe and increasing hip pain, swelling, severe metal-on-metal reaction with extremely high elevated serum cobalt and chromium levels.The bhr cup and bhr head were removed during surgery.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.The 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 well until 6 months before the revision, when pain started.During the revision a large amount of fluid came out of the joint, there was a lot of stained soft tissue with synovial reaction, at least half the acetabular bone was replaced by reactive tissue with significant metal debris and there were cystic structures inferiorly and medially to the acetabulum.Based on the provided information the findings are consistent with an inflammatory reaction but no contributing factors or other relevant information was provided to conclude on a root cause that could explain the later revision.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: 7192791
• MDR Text Key: 97288270
• Report Number: 3005975929-2018-00019
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Catalogue Number: 74120156
• Device Lot Number: 62185
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121150/RESURFACING FEMORAL HEAD 50MM/60915; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR