MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE USE WITH PLATE 5,6 SIZE GREEN/C-H 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.Our investigation is ongoing.A follow-up/final report will be submitted when additional information becomes available.Concomitant medical products.: nexgen cruciate retaining cr-flex femoral component, catalog # 00575201601, lot # 63513059, nexgen trabecular metalâ?¢ standard primary patella, catalog # 00587806535, lot # 63522632, headless trocar drill pin, catalog # 00590102000, lot # 63552809, tibial tray fixed bearing size 5, catalog # 00595404701, lot # 63276213.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-01202.
Event or Problem Description
It was reported that the patient underwent an initial knee arthroplasty two years ago.Subsequently, the patient was revised due to tibial and articular surface loosening.Attempts have been made and additional information on the reported event is unavailable.No additional patient consequences were reported.
Additional Manufacturer Narrative
Reported event was confirmed by review of pictures and video.Visual examination of the provided photos showed bodily material on the tibial tray and articular surface, confirming devices were removed from the patient.A video also showed the articular surface being lifted off of the tibial tray using a surgical tool at the front edge of the articular surface and tibial tray.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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: ARTICULAR SURFACE USE WITH PLATE 5,6 SIZE GREEN/C-H 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9386625
• Report Number: 0001822565-2019-05103
• Device Sequence Number: 479919
• Product Code: JWH
• UDI-Device Identifier: 00889024208018
• UDI-Public: (01)00889024208018
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K003910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00595204010
• Device Lot Number: 63544483
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 70