MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L; HIP COMPONENT

Model Number	PHA04406
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, trouble occurrence during bedside rehabilitation, an abnormality was noticed and cup dislocation was confirmed by radiography.During the healing process, the neck was also dislocated, and the patient underwent revision.Doctor's finding: the patient originally had a standing acetabulum and problem was progressing, and while the dislocation was expected, the fact that the neck was dislocated was not.The patient requested an investigation.According to the x-rays, the neck and the stem were dislocated, this should not have happened, since these devices must be fixed, so it is presumed that these components were dissociated from each other.Japan (b)(4).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L
• 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: 15743813
• Report Number: 3010536692-2022-00403
• Device Sequence Number: 5851018
• Product Code: LZO
• UDI-Device Identifier: M684PHA044061
• UDI-Public: M684PHA044061
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/08/2023

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: PHA04406
• Device Catalogue Number: PHA04406
• Device Lot Number: 1899205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2022
• Supplement Date Received by Manufacturer: 10/23/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 02/08/2023
• 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: 77 YR
• Patient Sex: Female