MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® BF SHELL 52MM GROUP D; HIP COMPONENT

Model Number DSBFGD52

Device Problems Loss of Osseointegration (2408); Malposition of Device (2616); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluate.

Event Description

Allegedly, the patient underwent a thr and presented pain, diagnosis of loose acetabular cup that was misaligned causing increased leg lengthening.Received a revision where microport cup, liner and screw were removed and replaced with another company's implants.The femoral head was removed and replaced it with a microport implant head.Femoral stem component remained well fixed.C926.

• Brand Name: DYNASTY® BF SHELL 52MM GROUP D
• 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: 9788335
• MDR Text Key: 182152233
• Report Number: 3010536692-2020-00189
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684DSBFGD521
• UDI-Public: M684DSBFGD521
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K082924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DSBFGD52
• Device Catalogue Number: DSBFGD52
• Device Lot Number: 1628187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2020
• Date Manufacturer Received: 02/13/2020
• 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
• Patient Age: 77 YR