MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® PLASMA Z CLASSIC SIZE 7 STRAIGHT SHORT N; HIP COMPONENT

Model Number	PHAPCLS7
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the stem has no porous coating on it and it was implanted.This was determined as part of an internal mpo risk assessment (r22040001) linked to a previous complaint investigation (incident 22040055).No serious injury has been confirmed, however there is a potential risk of serious injury.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PROFEMUR® PLASMA Z CLASSIC SIZE 7 STRAIGHT SHORT N
• 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: 14289284
• Report Number: 3010536692-2022-00158
• Device Sequence Number: 12143573
• Product Code: LPH
• UDI-Device Identifier: M684PHAPCLS71
• UDI-Public: M684PHAPCLS71
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123434
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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: Health Professional
• Device Model Number: PHAPCLS7
• Device Catalogue Number: PHAPCLS7
• Device Lot Number: 1903727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 05/05/2022
• 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: 66 YR
• Patient Sex: Male