MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE CEMENTLESS FEMORAL COMPONENT 44MM; HIP COMPONENT

Model Number 38PF1044

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Reaction (2414); Metal Related Pathology (4530)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, the subject began with pain consistently, a pseudotumor was diagnosed through ultrasound.Revision with full implant removal occurred.

Manufacturer Narrative

See memo attached.- attachment: [8.Memorandummomwd011615_02_1.Pdf].

Event Description

Allegedly, on (b)(6) 2016 subject began with pain, a pseudotumor was diagnosed through ultrasound.Revision with full implant removal occurred on (b)(6) 2019.Additional information on (b)(6) 2018 subject experienced hip dislocation of the right side and received a reduction on (b)(6) 2018.Sae # 052-021r-2.Additional information received on 11/09/2020 from clinical: correcting explant date to (b0(6) 2019 and patient's personal information.

Manufacturer Narrative

No change to the evaluation previously reported.

• Brand Name: CONSERVE CEMENTLESS FEMORAL COMPONENT 44MM
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9739378
• MDR Text Key: 180518468
• Report Number: 3010536692-2020-00148
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: M68438PF10441
• UDI-Public: M68438PF10441
• Combination Product (y/n): N
• PMA/PMN Number: K082673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 38PF1044
• Device Catalogue Number: 38PF1044
• Device Lot Number: 1451877
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/31/2020
• Date Manufacturer Received: 01/31/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 46