MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE® DURAMER® ACETABULAR LINER 22.25 15DG STD; HIP COMPONENT

Model Number 36452200

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, lin bin's first hip was not matched with the no.42 outer cup and the no.0 inner lining.As a result, there were a lot of problems with the chain reaction.He cracked the acetabulum for more than 6 hours and almost couldn't get off the stage.

• Brand Name: LINEAGE® DURAMER® ACETABULAR LINER 22.25 15DG STD
• 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: 13154223
• MDR Text Key: 285698427
• Report Number: 3010536692-2022-00005
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M684364522001
• UDI-Public: M684364522001
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K002149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

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: 36452200
• Device Catalogue Number: 36452200
• Device Lot Number: 1748751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/15/2021
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 03/01/2022
• 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: 43 YR
• Patient Sex: Male