MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE GH 10 MM HEIGHT "USE WITH PLATE 7; PROSTHESIS, KNEE

Catalog Number	00596405010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: femoral component, #item 00596401752, #lot 65985787.Inset all poly petella, #item 00597206526, #lot 66769392.Stemmed tibial component, #item 00598005701, #lot j7812310.Therapy date: (b)(6) 2026.G2: foreign report source spain.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient has experience discomfort in his knee approximately 2 years post implantation, he underwent a scintigraphy, which revealed tibial loosening, so a knee revision was scheduled.The patient had a revision surgery 2 years post implantation, and the polyethylene has been replaced, as no loosening was observed in the tibial and femoral implants.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
Attempts have been made and additional information on the reported event is unavailable at this time.
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.Complaint not confirmed no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.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.

• Brand Name: ARTICULAR SURFACE SIZE GH 10 MM HEIGHT "USE WITH PLATE 7
• 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: 24442724
• Report Number: 0001822565-2026-00606
• Device Sequence Number: 10364039
• Product Code: JWH
• UDI-Device Identifier: 00889024635203
• UDI-Public: (01)00889024635203(17)290731(10)66827268
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: Lay User/Patient
• Device Catalogue Number: 00596405010
• Device Lot Number: 66827268
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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 NARRATIVE; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male