MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE® TRANSCEND® CERAMIC ACETABULAR LINER; HIP COMPONENT

Model Number 72003252

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, broken ceramic liner, the cup revised and new biolox head with sleeve implanted.The cup was damaged in the removal process.Components not revised: product: profemur® neck neutral long product id: pha01204, lot#: 038561200 qty:1.Product: profemur® tl stem sz 3 product id: prtl0023, lot#: 027395031, qty:1.

• Brand Name: LINEAGE® TRANSCEND® CERAMIC ACETABULAR 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: 14800294
• MDR Text Key: 295055914
• Report Number: 3010536692-2022-00234
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: M684720032521
• UDI-Public: M684720032521
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

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: 72003252
• Device Catalogue Number: 72003252
• Device Lot Number: 086372088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/01/2022
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 06/01/2022
• Supplement Dates FDA Received: 08/09/2022
• 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
• Patient Age: 52 YR
• Patient Sex: Male