MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL IMPACTOR BLOCK; INSTRUMENT, KNEE

Catalog Number	00590103200
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 a reported a crack was discovered on a persona femoral impactor head.No patient involvement was reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; h2; h3; h6.Visual examination of the provided picture identified a femoral impactor block with the part and lot information identifiable.The complaint can be confirmed as the device was cracked and showed signs of wear with surface marks/scratches visible, the device has a potential field age of 14 years.No product was returned therefore no further evaluations can be made.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 is available at the time of this report.

• Brand Name: FEMORAL IMPACTOR BLOCK
• Common Device Name: INSTRUMENT, 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: 23405518
• Report Number: 0001822565-2025-03875
• Device Sequence Number: 4902276
• Product Code: LXH
• UDI-Device Identifier: 00889024201668
• UDI-Public: (01)00889024201668(10)61679824
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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 Catalogue Number: 00590103200
• Device Lot Number: 61679824
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown