MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE EF 10 MM HEIGHT "USE WITH PLATE 3; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2019-03666.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 the articular surface would not seat in the tibial tray.After surgery, the clinician found that there were indentations in the card slot on the back of the gasket.There is no additional information at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.The reported event is considered confirmed.Product was returned and visual evaluation of articular surface shows that the dovetail feature was flared and compressed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.Damage to the dovetail feature can occur if the articular surface is not correctly placed and oriented before pushing it into the tibial plate using the inserter instrument.Detailed instructions for inserting the articular surface are provided in the zimmer mis multiple-reference 4 in 1 femoral instrumentation surgical technique and the surgical tip: articular surface inserter "proper technique & use" guidance document.The per states that the surgical technique was followed; however, the dovetail compression identified during the evaluation of the returned product indicates that the articular surface was not properly aligned before being pushed in with the inserter.The root cause is related to the surgical technique.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 SIZE EF 10 MM HEIGHT "USE WITH PLATE 3
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8939031
• Report Number: 0001822565-2019-03664
• Device Sequence Number: 328335
• Product Code: JWH
• UDI-Device Identifier: 00889024211889
• UDI-Public: (01)00889024211889
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00596403210
• Device Lot Number: 64227019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 02/03/2020
• 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