MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZSS DISTAL FEMORAL XT COMPONENT SIZE B RIGHT; PROSTHESIS, KNEE

Catalog Number	00585004202
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	06/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign country: australia.H6: mechanical (g04) - femur.Customer has indicated that the product will not be 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 the patient underwent a knee procedure.Approximately 4 years post-op, the patient was revised due to femoral loosening.The femoral component and poly were revised.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: (b)(6) - fluted stem extension straight precoat for cemented use only 19 mm diameter 130 mm length - (b)(6).(b)(6) - femoral hinge service kit size b - (b)(6).(b)(6) - stem collar 35 mm o.D.For use with 17 mm - 19 mm diameter segnmental stems - (b)(6).(b)(6) - stem collar 35 mm o.D.For use with 16 mm or smaller diameter segmental stems - (b)(6).(b)(6) - polyethylene insert xt size b use with distal femoral xt size b use with xt only - (b)(6).(b)(6) - articular surface with segmental hinge post size b 14 mm height - (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was further reported that the patient underwent a revision due to femoral loosening approximately 4 years post-op.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2.Upon reassessment of the reported event, it was determined to be not reportable as the device is not bone-interfacing.The initial report should be voided.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ZSS DISTAL FEMORAL XT COMPONENT SIZE B RIGHT
• 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: 22396195
• Report Number: 0001822565-2025-02360
• Device Sequence Number: 17378734
• Product Code: KRO
• UDI-Device Identifier: 00889024195936
• UDI-Public: (01)00889024195936(17)300228(10)64601440
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00585004202
• Device Lot Number: 64601440
• Was Device Available for Evaluation?: No
• 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: 06/21/2025
• Supplement Date Received by Manufacturer: 07/10/2025; 10/27/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/30/2025; 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female