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

Model Number	38PF1044
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Pain (1994); Reaction (2414); Metal Related Pathology (4530)
Date of Event	02/10/2016
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, the subject began with pain consistently, a pseudotumor was diagnosed through ultrasound.Revision with full implant removal occurred.
Additional Manufacturer Narrative
See memo attached.- attachment: [8.Memorandummomwd011615_02_1.Pdf].
Event or Problem 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.
Additional Manufacturer Narrative
No change to the evaluation previously reported.

• Brand Name: CONSERVE CEMENTLESS FEMORAL COMPONENT 44MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9739378
• Report Number: 3010536692-2020-00148
• Device Sequence Number: 618848
• Product Code: KXA
• UDI-Device Identifier: M68438PF10441
• UDI-Public: M68438PF10441
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2020

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: 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
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 01/31/2020; 01/31/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 05/27/2020; 11/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 46