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	Insufficient Information (4580)
Date of Event	11/17/2021
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, item implanted on (b)(6) 2021 without incident, patient presented at emergency room on (b)(6) 2021 with dislocation of head/liner construct form shell/liner.Closed reduction was attempted and unsuccessful.Patient was referred to (b)(6).Revising surgeon decided removal of all implants was in best interest of patient.Components successfully explanted on (b)(6) 2021.A sales representative was present at the process.Patient suffering from dementia and non-ambulatory.

• 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: 13101586
• Report Number: 3010536692-2021-00601
• Device Sequence Number: 3537739
• Product Code: LZO
• UDI-Device Identifier: M684PHA044061
• UDI-Public: M684PHA044061
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K140043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: PHA04406
• Device Catalogue Number: PHA04406
• Device Lot Number: 1850242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 02/16/2022
• 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: 89 YR
• Patient Sex: Female