MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE EF 14 MM HEIGHT "USE WITH PLATE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: femoral component option for cemented use only size e right, item#: 00599601552, lot#: 64432266.Stemmed tibial component precoat size 5, item#: 00598004701, lot#: 64368539.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 would not seat with the tibial tray.Repeated attempts were unsuccessful during the operation.After replacement of the same product, it was successfully implanted, and the operation was delayed for thirty minutes.There is no additional information available at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned product found signs of use (nicked or gouged) and the dovetail feature is flared and compressed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for inserting the articular surface are provided in lps-flex fixed bearing knee surgical technique (97-5964-102-00-rev0616) pg.15-17.The root cause is attributed to use error.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 14 MM HEIGHT "USE WITH PLATE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10133844
• Report Number: 0001822565-2020-02009
• Device Sequence Number: 3866599
• Product Code: JWH
• UDI-Device Identifier: 00889024211964
• UDI-Public: (01)00889024211964
• 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): 06/30/2020

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 Expiration Date: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 00596404014
• Device Lot Number: 63706803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 06/30/2020
• 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
• Patient Weight: 70