MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) TOTAL A-CLASS HEAD; HIP COMPONENT

Model Number 38AM-4804

Device Problem Noise, Audible (3273)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Orig.Surg.(b)(6) 2008.(b)(6) yrs old.Allegedly mr.(b)(6) total hip (right) squeaks intermittently.Dr.(b)(6) states the hip seems to clatter/rub during rom.Update: cup, head, and neck received by microport post market quality on 23 may 2018.The stem was not returned.The explant date is unknown.

• Brand Name: CONSERVE(R) TOTAL A-CLASS HEAD
• 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: 11015596
• MDR Text Key: 221733707
• Report Number: 3010536692-2020-00770
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38AM-4804
• Device Lot Number: 068605229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization