MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD MEDIUM NECK 36MM; HIP COMPONENT

Model Number 38AM3600

Device Problems Material Disintegration (1177); Device Dislodged or Dislocated (2923)

Patient Problems Metal Related Pathology (4530); Unequal Limb Length (4534)

Event Type  Injury  

Event Description

Allegedly, the patient underwent a revision surgery due to dislocation, metal debris with pseudo-tumor formation and leg length discrepancy.Component not revised: dspcgc50 dynasty® pc shell 50mm, group c, lot: 129999843.

• Brand Name: CONSERVE A-CLASS BFH HEAD MEDIUM NECK 36MM
• 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: 11230126
• MDR Text Key: 228672088
• Report Number: 3010536692-2021-00038
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: M68438AM36001
• UDI-Public: M68438AM36001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2021

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: Health Professional
• Device Model Number: 38AM3600
• Device Catalogue Number: 38AM3600
• Device Lot Number: 039828317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/05/2021
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/26/2021
• 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