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

Model Number	PHA04410
Medical Device Problem Codes	Crack (1135); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3010536692-2022-00208
• Device Sequence Number: 4956970
• Product Code: LZO
• UDI-Device Identifier: M684PHA044101
• UDI-Public: M684PHA044101
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female