MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122546

Device Problems Material Disintegration (1177); Loose or Intermittent Connection (1371); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to loosening and metallosis with pseudotumor formation, moderate trunnions, elevated levels of cobalt and chromium.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup, hemi head, modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the sleeve.Similar complaints have been identified for the cup.This will continue to be monitored.Similar complaints were found for the head.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.Although it was reported that metal ion levels were reported, no laboratory levels were provided.The reported intraoperative findings of metallosis, pseudotumor and dark stained fluid are consistent with findings associated with metal debris; however, the root cause of the reported clinical reactions cannot be confirmed, and it cannot be concluded that they were associated with a mal-performance of the implant.The patient impact beyond the pain, revisions, and expected transient post-op convalescence period cannot be determined.The patient impact beyond the revision cannot be concluded.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: HEMI HEAD 46MM
• 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: 9080362
• MDR Text Key: 161242874
• Report Number: 3005975929-2019-00330
• 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,Followup
• Report Date: 02/11/2021

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: 01/30/2012
• Device Catalogue Number: 74122546
• Device Lot Number: 10727
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 07/15/2020; 08/18/2020; 08/18/2020
• Supplement Dates FDA Received: 07/17/2020; 10/22/2020; 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71356007 ANTH SO PO SIZE 7 06CM04508; 74120152 ACETLR CUP HAP 52MM W/ IM 075850; 74222200 MOD SLEEVE PLUS 0MM 12/14 07LW14967
• Patient Outcome(s): Hospitalization; Required Intervention