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

Model Number 74122546

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Toxicity (2333)

Event Date 10/15/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to elevated chrome levels.Serum 2.9 ng/mm cobalt 16.2 ng/mm.

Manufacturer Narrative

It was reported that 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 and 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 hemi head and bhr cup.Similar complaints have been identified for the sleeve and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the known 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 a result of the reported event.Cobalt was stated to be 16.2 ng/mm.However, no clinical/medical documentation has been provided as support for this complaint.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.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: 9245578
• MDR Text Key: 163980074
• Report Number: 3005975929-2019-00387
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 00885556071588
• UDI-Public: 00885556071588
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

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: Lay User/Patient
• Device Expiration Date: 09/28/2012
• Device Model Number: 74122546
• Device Catalogue Number: 74122546
• Device Lot Number: 07JW13859
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP HAP 54MM 74120154/080030; MODULAR SLEEVE 74222200/ 07EW11882; ACETLR CUP HAP 54MM 74120154/080030; MODULAR SLEEVE 74222200/ 07EW11882
• Patient Outcome(s): Hospitalization; Required Intervention