MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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: 00584201502 femoral component high flex precoated, lot#: 63199765, mdr: 0001822565-2022-03463.Additional related products: 00584202309 articular surface size 3 9 mm ht, lot#: 63118426.
Additional Manufacturer Narrative
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 or Problem Description
No further event information available at the time of this report.

• Brand Name: TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3
• Common Device Name: 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: 15995637
• Report Number: 0001822565-2022-03462
• Device Sequence Number: 6089805
• Product Code: HSX
• UDI-Device Identifier: 00889024193635
• UDI-Public: (01)00889024193635(17)251130(10)11017646
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K033363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00584200302
• Device Lot Number: 11017646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 108 KG