MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® PLASMA Z CLASSIC SIZE 4 VARUS 8 DG LONG; HIP COMPONENT

Model Number	PHAPE238
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, unknown hip postoperative dislocation requiring revision.Additional information received on 12/10 from (b)(6) and lots from (b)(6) hospital, patient information, explant date.Only a femoral head and a stem are from (b)(6).The rest of the components are from another manufacturer.Right side.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PROFEMUR® PLASMA Z CLASSIC SIZE 4 VARUS 8 DG LONG
• 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: 13112239
• Report Number: 3010536692-2021-00608
• Device Sequence Number: 3510535
• Product Code: LPH
• UDI-Device Identifier: M684PHAPE2381
• UDI-Public: M684PHAPE2381
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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: PHAPE238
• Device Catalogue Number: PHAPE238
• Device Lot Number: 1726623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/23/2022
• 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: 64 YR
• Patient Sex: Unknown