MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) FEMORAL COMPONENT; HIP COMPONENT

Model Number	38PF1052
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Reaction (2414); Metal Related Pathology (4530)
Date of Event	08/07/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint will be updated once investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, patient revised due to metallosis.Right (b)(6).
Event or Problem Description
Allegedly, patient revised due to metallosis.Right sae# 052-040r002.Sade # 052-040r-6: patient had chronic irritation & pain bilaterally right worse than left.Small pseudotumor seen right hip, elevated metal ion levels detected.R hip was revised, all original components removed.

• Brand Name: CONSERVE(R) FEMORAL COMPONENT
• 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: 6191243
• Report Number: 3010536692-2016-01536
• Device Sequence Number: 376912
• Product Code: KXA
• UDI-Device Identifier: M68438PF10521
• UDI-Public: M68438PF10521
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2023

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: 38PF1052
• Device Catalogue Number: 38PF1052
• Device Lot Number: 1477482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided; 12/14/2016
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 02/15/2017; 03/03/2023
• 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: Male