MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD SHORT NECK 50MM; HIP COMPONENT

Model Number 38AM5004

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

See investigation attached.

Event Description

Allegedly, the patient was revised due to metallosis (no pseudotumor) and the failure of modular neck at the neck/stem junction taper (neck broken).

Event Description

Allegedly, the patient was revised due to failure of the modular neck at the neck/stem junction taper (fractured neck).The revision operative notes also lists, "moderate metallosis (no pseudotumor)" as an intraoperative finding.

Manufacturer Narrative

Updated incident description.All previous information including the investigation remain the same.

• Brand Name: CONSERVE A-CLASS BFH HEAD SHORT NECK 50MM
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11585808
• MDR Text Key: 242881689
• Report Number: 3010536692-2021-00180
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: M68438AM50041
• UDI-Public: M68438AM50041
• Combination Product (y/n): N
• PMA/PMN Number: K021349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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: Other
• Device Model Number: 38AM5004
• Device Catalogue Number: 38AM5004
• Device Lot Number: 065229812
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2021
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 05/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR