MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE SIZE EF 10 MM HEIGHT "USE WITH PLATE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: china.D10: 00598004701; stemmed tibial component precoat size 5 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten; 66105827 42500606401; femur cemented posterior stabilized (ps) standard left size 8; 66541580 00598801212; 12.7mm diameter 30mm length straight stem extension combined length 75mm; 66662137 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 during surgery the articular surface could not assemble the matting tibial tray.The surgical technique was utilized; there was a 5 mins delay.No harm occurred and no foreign bodies were retained.A second device was used to complete the surgery.Attempts have been made, and all available information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h4; h6 the event is confirmed.Visual examination of the returned product identified signs of insertion attempt/s (gouges, inserter tool marks) and the dovetail feature is flared and compressed.Dimensional analysis of the product determined that the product, where measured, was conforming to its print specifications.The device history record was reviewed and no discrepancies relevant 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.Medical records were not provided.Damage to the articular surface can occur if the articular surface is not placed as intended and oriented before pushing it using the inserter instrument.Detailed instructions for proper bearing insertion are provided in the surgical technique document for this device.The document also warns that the bearing should be inserted only once ¿only insert a bearing once.Never reinsert the same bearing onto a tibial tray" (page 47).The root cause is attributed to use error via a failure to follow instructions.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: NEXGEN ARTICULAR SURFACE SIZE EF 10 MM HEIGHT "USE WITH PLATE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22242118
• Report Number: 0001822565-2025-01988
• Device Sequence Number: 8976630
• Product Code: JWH
• UDI-Device Identifier: 00889024634992
• UDI-Public: (01)00889024634992(17)291008(10)66940307
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/04/2025

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: 00596404010
• Device Lot Number: 66940307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: Asian