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	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	06/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Allegedly primary surgery was performed on (b)(6) 2019.Two weeks after the operation, the patient pointed out that "the rattle noise occurs in the body", and the sound disappeared a few days later, but when ct was taken, the 32 mm head was acetabular.Because it was at a position offset from the lid cup, it is presumed that the polyethylene liner was likely to be dislocated, and day 21 poly liner removal + replacement surgery was performed.
Event or Problem Description
Allegedly primary surgery was performed on (b)(6) 2019.Two weeks after the operation, the patient pointed out that "the rattle noise occurs in the body", and the sound disappeared a few days later, but when ct was taken, the 32 mm head was acetabular.Because it was at a position offset from the lid cup, it is presumed that the polyethylene liner was likely to be dislocated, and day 21 poly liner removal + replacement surgery was performed.

• 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
• MDR Report Key: 8798022
• Report Number: 3010536692-2019-00905
• Device Sequence Number: 335021
• Product Code: LZO
• UDI-Device Identifier: M684PHA044101
• UDI-Public: M684PHA044101
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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: Health Professional
• Device Model Number: PHA04410
• Device Catalogue Number: PHA04410
• Device Lot Number: 1789272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 02/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR