MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD 26MM 0MM; HIP COMPONENT

Model Number 26012602

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, bipolar cup breakaway detected.Doctor's findings it seems that some strong power was added and it came off.The reporter's findings: he thinks that he was dislodged by an excessively strong impact, or that he did not enter properly from the beginning.

• Brand Name: FEMORAL HEAD 26MM 0MM
• 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: 9955197
• MDR Text Key: 187514591
• Report Number: 3010536692-2020-00341
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 26012602
• Device Catalogue Number: 26012602
• Device Lot Number: 1820305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/26/2020
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention