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

Catalog Number 3645-28X3

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.

Event Description

Allegedly, during surgery, the hospital found a mismatch between the insert and the packaging.It is alleged that the insert is bigger than the packaging suggests and has a visor.In addition the insert contains the following inscription on the top ring: "28mm grp 3 mpo 1653302 xluhmwpe" and has no information about the necessary catalogue number.It is alleged, therefore, that a mistake has been made during the repacking of goods into wmp for cmt.

• 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: 6120326
• MDR Text Key: 60647738
• Report Number: 3010536692-2016-01251
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2016

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: Physician
• Device Catalogue Number: 3645-28X3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/26/2016
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 11/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention