MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY(R) COCR LINER; HIP COMPONENT

Catalog Number DLCO-GG44

Device Problems Sticking (1597); Metal Shedding Debris (1804); Noise, Audible (3273)

Patient Problems Pain (1994); Toxicity (2333); Fluid Discharge (2686); Test Result (2695); No Code Available (3191)

Event Date 07/10/2013

Event Type  Injury  

Event Description

Allegedly, patient was revised due to mom complication: elevated cocr ions; pain; squeaking; catching; metallosis; pseudotumor; fluid collections; - right.

Manufacturer Narrative

This is the same event as 3010536692-2015-00810.

• Brand Name: DYNASTY(R) COCR 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 ; 901867-441
• MDR Report Key: 4746826
• MDR Text Key: 5771287
• Report Number: 3010536692-2015-00809
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: DLCO-GG44
• Device Lot Number: 049830312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/10/2013
• Event Location: Hospital
• Date Manufacturer Received: 04/08/2015
• 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: 59 YR