MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 2; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2020-02711.Concomitant medical products: femoral component high flex precoat right medial/left lateral, item# 00584201502, lot# 11017127.Articular surface size 2 8 mm height femoral size a,b,c,d,e,f,g, item# 00584202208, lot# 62972567.Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was revised approximately four years and two months post implantation due to aseptic loosening.There is no additional information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the provided pictures identified implant with bone cement/tissue/bone attached to back of the implant.Some wear was seen in the articular surface.No further evaluation can be made from the provided picture.Medical records were not provided.However, review of small note provided by the customer noted no issue during the initial surgery.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.Per package insert 87-6203-012-01: loosening is known adverse effect of the procedure.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 Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Examination of the returned implants showed signs of implantation.The backside of both femoral and tibial implants contained foreign material that resembled bone cement.The root cause remains unchanged with the information provided.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.
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 2
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10333311
• Report Number: 0001822565-2020-02712
• Device Sequence Number: 3222827
• Product Code: HSX
• UDI-Device Identifier: 00889024193611
• UDI-Public: (01)00889024193611
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2025
• Device Model Number: N/A
• Device Catalogue Number: 00584200202
• Device Lot Number: 11017015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/24/2020; 11/13/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/30/2020; 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention