MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZSS POLYETHYLENE INSERT XT SIZE C; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00585003020 - articular surface with segmental hinge post size c 20 mm height - 65777531.00585004302 - distal femoral xt component size c right use with polyethylene insert xt size c use with xt only for cemented use only in the u.S.A - 66324198.00588000302 - size 3 precoat non-modular cemented tibial component - 66081854.00585205010 - fluted stem extension straight precoat 10 mm diameter 130 mm length for cemented use only - 66108375.42540200035 - all-poly patella cemented 35 mm diameter - 66068865.G2 : foreign country : australia.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 that a patient underwent a knee arthroplasty.Subsequently, the patient was revised approximately 8 months post-op due to instability.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 event cannot be confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.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 POLYETHYLENE INSERT XT SIZE C
• 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: 20896291
• Report Number: 0001822565-2024-03905
• Device Sequence Number: 8773194
• Product Code: KRO
• UDI-Device Identifier: 00889024633896
• UDI-Public: (01)00889024633896(17)280908(10)66148645
• 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: 2024
• Device Explanted Year: 2024
• 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): 03/05/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585001396
• Device Lot Number: 66148645
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female