MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122550

Device Problems Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

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

Event Date 02/02/2017

Event Type  Injury  

Event Description

It was reported that revision surgery was performed to metallosis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the hemi head and modular sleeve were removed.The bhr cup and synergy stem remained implanted.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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.Although cobalt and chromium levels were reported as 7.9 and 4.5 respectively, no units of measure were given nor was a laboratory report provided.The reported pain and intraoperative findings of trunnionosis and inflammation are consistent with findings associated with metallosis, however, the root cause cannot be determined nor can it be concluded that the clinical reactions are associated with a mal-performance of the implant.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 50MM
• 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: 6368120
• MDR Text Key: 68660369
• Report Number: 3005477969-2017-00001
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2019

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 Catalogue Number: 74122550
• Device Lot Number: 10550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided; 02/02/2017
• Supplement Dates FDA Received: 05/11/2017; 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP 74120156/ 078092; HEMI HEAD, # 74122550, LOT # UNKNOWN; MODULAR SLEEVE 74222100/ 10056; MODULAR SLEEVE, # 74222000, LOT # UNKNOWN; SYN POR STEM 71309015/ 07JM19314A; HEMI HEAD, # 74122550, LOT # UNKNOWN; MODULAR SLEEVE, # 74222000, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention