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

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign : (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Nexgen poly insert (articular surface) was unable to lock with tibia.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow up is being submitted to relay additional information.D10: medical product: stemmed tibial component precoat size 4: catalog#00598003702, lot#63068858.Visual examination of the returned product identified damage to the distal surface (nicked/gouged) and the dove tail/locking features to be compressed and flared out.Device history record was reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Investigation results concluded that the reported event was due to use error.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 the surgical technique.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARTICULAR SURFACE SIZE EF 14 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12525241
• Report Number: 0001822565-2021-02758
• Device Sequence Number: 1101080
• Product Code: JWH
• UDI-Device Identifier: 00889024211902
• UDI-Public: (01)00889024211902(17)271231(10)64626171
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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 Model Number: N/A
• Device Catalogue Number: 00596403214
• Device Lot Number: 64626171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 Sex: Unknown