MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122548

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Toxicity (2333); Injury (2348)

Event Date 03/19/2019

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to metallosis as indicated by elevated metal ions in blood.

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 anthology 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 elevated cobalt and chromium levels, pseudotumor, and trunnions are consistent with findings associated with metallosis; the root cause cannot be confirmed, and it cannot be concluded that the reported clinical reactions were 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.

Event Description

It was reported that right hip revision surgery was performed due to mom failed, trunnionosis and highly elevated metal ions in blood.

• Brand Name: HEMI HEAD 48MM
• 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: 8621656
• MDR Text Key: 145472326
• Report Number: 3005975929-2019-00213
• 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
• Report Date: 11/10/2019

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 Expiration Date: 09/30/2012
• Device Catalogue Number: 74122548
• Device Lot Number: 07JW13873
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 11/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71357005/ ANTHOLOGY SO POR PL HA SZ 5/ 08LM05664A; 74122154/ ACETAB CUP HAP SIZE 48/54 /08CW16030; 74222200/ MODULAR SLEEVE 0MM 12/14 / 08HW18187
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR