MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® Z STEM; HIP COMPONENT

Model Number	PHA00234
Medical Device Problem Codes	Corroded (1131); Material Disintegration (1177)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Reaction (2414)
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, patient presented elevated cobalt ion levels and pain.The device failed due to corrosion at the neck-stem junction of the device, corrosion on the oblong taper where the neck was seated in the pocket of the profemur titanium stem, which caused adductor damage, soft tissue reaction and pseudotumor reaction.During the revision the surgeon removed the failed components of the profemur total hip system.
Additional Manufacturer Narrative
Updated patient information and event codes.This event is related to reports 3010536692-2019-00438, 3010536692-2019-00439 and 3010536692-2019-00440.
Additional Manufacturer Narrative
Corrected patient and device codes.

• Brand Name: PROFEMUR® Z STEM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9733090
• Report Number: 3010536692-2020-00144
• Device Sequence Number: 3270124
• Product Code: LPH
• UDI-Device Identifier: M684PHA002341
• UDI-Public: M684PHA002341
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2020

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: PHA00234
• Device Catalogue Number: PHA00234
• Device Lot Number: 0411347675
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 01/28/2020; 01/28/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 02/21/2020; 05/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention