MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M; HIP COMPONENT

Model Number PHA04410

Device Problems Crack (1135); Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the ct report on (b)(6) 2021 shows a dislocation of the acetabular part of the hip endoprosthesis, osteolysis and pain.The same result also shows that older radiographs show a significant reaction in the area of the left hip with layers along the left hip prosthesis.Px performed an x-ray on (b)(6) 2021 and the results show that there was thinning of the bone in the acetabular part of the endoprosthesis and in the femur.Loss of mobility due to pain.Products not revised, allegedly revision surgery scheduled for (b)(6) 2022.

Manufacturer Narrative

Due to additional information received, it has been indicated the complaint does not allege deficiency in the product.Please void this report.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M
• 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: 14543610
• MDR Text Key: 293293399
• Report Number: 3010536692-2022-00208
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684PHA044101
• UDI-Public: M684PHA044101
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K130376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA04410
• Device Catalogue Number: PHA04410
• Device Lot Number: 1457575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/10/2022
• Date Manufacturer Received: 05/10/2022
• 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: 65 YR
• Patient Sex: Female