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

Model Number	PHA04404
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
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, her operating surgeon found a failure of left total hip prosthesis so the patient had to be revised.Components not revised: dynasty® pc shell 48mm group b / product id: dspcgb48 / lot no.: 1657397.Profemur® renaissance® classic rdc flare sz11 v8dg short neck / product id: plser011 / lot no.: 1491759.
Additional Manufacturer Narrative
Corrected data: medical device problem code is 2993 (adverse event without identified device or use problem) please void this report.

• 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: 12418328
• Report Number: 3010536692-2021-00490
• Device Sequence Number: 3332818
• Product Code: LZO
• UDI-Device Identifier: M684PHA044041
• UDI-Public: M684PHA044041
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K140043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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: PHA04404
• Device Catalogue Number: PHA04404
• Device Lot Number: 1653750
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2021
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention