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

Model Number	PHA04404
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to dislocation.Implant was removed and replaced.(b)(6).

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 M
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10538036
• Report Number: 3010536692-2020-00623
• Device Sequence Number: 373217
• Product Code: LZO
• UDI-Device Identifier: M684PHA044041
• UDI-Public: M684PHA044041
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K140043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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: PHA04404
• Device Catalogue Number: PHA04404
• Device Lot Number: 15538091754535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR