MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR FEMORAL HEAD 28MM SLT TAPER +0MM NECK; HIP COMPONENT

Model Number	26012802
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/18/2022
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, the femoral head disengaged from the bipolar head unexpectedly.Non-revised products: product id: pha00232, profemur® z femoral stem s 1 cement less/ lot number: 1897645/ qty.1.
Additional Manufacturer Narrative
Due to additional information received, it has been indicated that the patient had a fall in the bathroom and the head disengaged unexpectedly from the bipolar cup.This event was caused by the patient fall and the incident is not related to a device failure.Please void this report.
Event or Problem Description
Allegedly, the patient underwent bipolar hemiarthroplasty and used the above five implants on (b)(6) 2022.After the surgery, the patient slipped in the bathroom on (b)(6) 2022 and the femoral head disengaged from the bipolar head unexpectedly.The physician operated to replace the neck 8dg a/r (pha01232) with the neck 15dg a/r (pha01242) on (b)(6) 2022.The other four implants (cup, head, liner, stem) didn't have been replaced.

• Brand Name: COCR FEMORAL HEAD 28MM SLT TAPER +0MM NECK
• 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: 14409502
• Report Number: 3010536692-2022-00198
• Device Sequence Number: 20212275
• Product Code: LPH
• UDI-Device Identifier: M684260128021
• UDI-Public: M684260128021
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K932222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/17/2022

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: 26012802
• Device Catalogue Number: 26012802
• Device Lot Number: 1881487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 05/18/2022
• 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 Sex: Unknown