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

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was having a total knee arthroplasty a polyethylene tibial insert was opened and a manufacturing defect was noted on its lower surface.The defect prevented the correct adjustment of the tibial insert to the tibial metal component, leaving it loose and making it impossible to fit.Another insert was opened and used to complete the procedure.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Complaint is confirmed.Visual examination of the returned product identified signs of use (nicked/gouged) and the dovetail feature is compressed and flared out.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.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 [nexgen lps-flex fixed bearing knee surgical technique.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.

• Brand Name: ARTICULAR SURFACE SIZE EF 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11278810
• Report Number: 0001822565-2021-00312
• Device Sequence Number: 11404188
• Product Code: JWH
• UDI-Device Identifier: 00889024211940
• UDI-Public: (01)00889024211940(17)260831(10)64137701
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K991581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00596404010
• Device Lot Number: 64137701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/26/2021
• 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: ITEM 00598004702, LOT 64367395.; ITEM 00598004702, LOT 64367395.
• Patient Age: 57 YR