MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. UNKNOWN RIM-LOCK LINER; HIP COMPONENT

Model Number PHA04XXX

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, patient underwent in (b)(6) 2010 replacement of the right hip by means of a metal-metal prosthesis implantation, has developed pseudo-tumor from metal-metal coupling, with evidence of a cobalt dosage of 7.7 mg / l (compared to reference <1.0mg / l), causing aseptic loosening of the prosthesis and forcing it to undergo a prosthetic revision in 2014, of increased complexity due to the presence of the tumor mass.More tools since the onset of metallosis and, even more so, the development of pseudo-tumor represent clear typical consequences of metal / metal combinations.Only part numbers and lot numbers for the cup and stem were provided.

Manufacturer Narrative

Complete product id is obtained due to additional information received for this event.The received complete product id belongs to a device that is not commercially available in the usa.Therefore, this device is no longer needed to be reported.Please void this report.

• Brand Name: UNKNOWN RIM-LOCK LINER
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 15864992
• MDR Text Key: 304291913
• Report Number: 3010536692-2022-00422
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA04XXX
• Device Catalogue Number: PHA04XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/28/2022
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention