MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT HIGH FLEX PRECOATED; PROSTHESIS, KNEE

Model Number N/A

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 12/16/2020

Event Type  Injury  

Event Description

It was reported initial right unicompartmental arthroplasty.Subsequently revised 2 years 7 months post implantation due to pain, decreased adls, limited rom, and malposition of implant.During the revision it was confirmed femur in varus position and well fixed.Patient was revised without complications.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was not returned by the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs 00584200302 tibial component precoat rt medial/lt lateral size 3 lot# 11017646.Mdr: 0001822565-2022-03462.Additional related products: 00584200302 tibial component precoat right medial/left lateral size 3 lot# 11017646.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  h6-component code- suggested code: mechanical g4-femur.Visual examination of the provided pictures shows only implants.Both femur and tibial plate have bone cement adhered to them.Review of the device history record identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following that the patient was presented with pain with rom issue.X-ray found that the malposition on the femur side and tibial in unusual position.During the revision surgery, tibial and femur was appeared well fixed and both removed with minimal bone loss.Femur was noted be in some varus position.No complication was noted.The complaint is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Additional associated products & mdrs.00584202309 articular surface size 3 9 mm height lot#: 63118426.Unk bone cement lot#: unk.

Event Description

No further event information available at the time of this report.

• Brand Name: FEMORAL COMPONENT HIGH FLEX PRECOATED
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15995612
• MDR Text Key: 305604770
• Report Number: 0001822565-2022-03463
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00889024633650
• UDI-Public: (01)00889024633650(17)230731(10)63118426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00584201502
• Device Lot Number: 63199765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 108 KG