MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE PC SOLID SPIKE HEMI FLR STD SHELL SZ 56 G; LINEAGE HIP SHELL

Model Number 36550056

Device Problem Material Disintegration (1177)

Patient Problems Reaction (2414); No Information (3190)

Event Type  Injury  

Event Description

Allegedly, the hip was revised due to metallosis behind cup.The patient was revised to stryker shell with change of femoral head.Products not revised: perfecta® rs ii standard flare collarless size 14.2 39021420.

Manufacturer Narrative

Updated the event problem codes and investigation for this component.

• Brand Name: LINEAGE PC SOLID SPIKE HEMI FLR STD SHELL SZ 56 G
• Type of Device: LINEAGE HIP SHELL
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9440079
• MDR Text Key: 169925148
• Report Number: 3010536692-2019-01169
• Device Sequence Number: 1
• Product Code: LZO
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 36550056
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/15/2019
• Date Manufacturer Received: 11/14/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention