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	Difficult to Insert (1316)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); No Code Available (3191)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2019-03679.Concomitant medical products: unknown nexgen tibial tray.Report source - (b)(6).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 an articular surface could not be seated to the tibial tray.The surgeon placed the articular surface on to the tibia base plate, and then he hit the articular surface on the anterior edge with the palm of his hands a couple of times with some force as he also said ¿ouch¿ and shook his hand in discomfort.He then took the bearing inserter tool and attempted to lock it in place but the articular surface wouldn¿t seat.After four attempts to reinsert the articular surface it was clear there was an unknown issue causing it to not lock into the tibial tray.There was only one articular surface that was the correct height in the loan kit.The surgeon attempted to down size the tibial plate, but the peg holes were in a different position than had already been drilled.It was then decided the only option was to recut the tibia and take an additional two millimeters and then insert the taller articular surface.These extra steps were taken and the surgery was then completed.There is no additional information at this time.
Additional Manufacturer Narrative
Concomitant medical products: tibial tray fixed bearing size 4 item# 00595403702 lot# 64227091.
Event or Problem Description
No further event information available at the time of this report.
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 evaluation of the provided picture shows some damages to the dovetail of the articular surface; which looks it was compressed but cannot confirm.No other information can be obtained.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.The root cause of the reported issue is attributed to the user, not following instructions in ifu and off label use as he trying to use incompatible implants together.Package insert states not to use this product for other than labeled indications (off-label use) and appropriate matching of components will occur when the femoral and tibial baseplate colors and/or sizes are matched to the articular surface label.Mismatching may result in poor surface contact and could produce pain, decrease wear resistance, produce instability of the implant, or otherwise reduce implant life.Also, during the investigation, we noted that the surgeon was not using the articular inserter to seat the articular surface and hitting the articular with hand to seat it.Detailed instructions for inserting the articular surface are provided in the surgical technique and the surgical tip: articular surface inserter "proper technique & use" guidance document and per package insert avoid notching, scratching, or striking the device.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.

• 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: 8939074
• Report Number: 0001822565-2019-03678
• Device Sequence Number: 335952
• Product Code: JWH
• UDI-Device Identifier: 00889024208018
• UDI-Public: (01)00889024208018
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00595204010
• Device Lot Number: 63988419
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 03/02/2020; 03/16/2020
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 03/12/2020; 03/17/2020
• 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
• Outcome Attributed to Adverse Event: Other