MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE(R) DURAMER(R) ACETABULAR LINER; HIP COMPONENT

Catalog Number 3645-2200

Device Problem Component Incompatible (1108)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trends will be evaluated.

Event Description

Allegedly, the liner is smaller than acetabular cup, and isn't matching with the cup.That caused the surgery time to extend great than 30 mins.

• Brand Name: LINEAGE(R) DURAMER(R) 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: 6266221
• MDR Text Key: 65372736
• Report Number: 3010536692-2017-00034
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 3645-2200
• Device Lot Number: 1357827
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/17/2017
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention