MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 60MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120160

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Toxicity (2333); Injury (2348); No Code Available (3191)

Event Date 08/19/2015

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to severe adverse soft tissue reaction; highly elevated cobalt and chromium levels; pseudotumor.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to severe adverse soft tissue reaction, highly elevated cobalt and chromium levels and pseudotumor.During surgery, the bhr cup and the 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 revision report, there was a large adverse tissue reaction of the posterior aspect of the hip joint with amorphous material, a large cystic cavity in the pseudocapsule and the components were well fixed.As the explanted device was not available for analysis, it remains unknown whether the reported findings correspond to an increased amount of wear.Without further information such as histopathological analysis, blood metal ion levels and x-rays, the nature of the reported findings cannot be further investigated.Furthermore, possible factors that can negatively influencing implant survival or that can contribute to the reported findings could not be independently assessed or excluded.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 60MM 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, CV313 HL; UK CV313HL
• MDR Report Key: 8036401
• MDR Text Key: 126062805
• Report Number: 3005975929-2018-00412
• Device Sequence Number: 0
• Product Code: NXT
• 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: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 74120160
• Device Lot Number: 087030
• Date Manufacturer Received: 10/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121154/RESURFACING FEMORAL HEAD 54MM/080726
• Patient Outcome(s): Hospitalization; Required Intervention