MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 5; PROSTHESIS, KNEE

Catalog Number	42502606801
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A journal article was retrieved from knee surgery, sports traumatology, arthroscopy that reported a study from denmark.The study reported one patient from the mc group had a tka revision surgery to a knee with tibia stem lengthening at 24 months follow-up due to pain and restricted rom in both flexion and extension.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: 42512100810 - articular surface mc - 63987641.4711500396-1 - optipac-s 60 refob - a747c05665.42540000035 - all poly patella - 64087381.42532007501 - tibia cemented - 64072030.G2: foreign - event occurred in denmark.G2: literature - burvil, c.C.H., linde, k.N., stilling, m., hansen, t.B., dalsgaard, j., rytter, s., koppens, d., & petersen, e.T.(2025).Similar fixation of total knee arthroplasty components with medial congruent and cruciate retaining polyethylene inserts.A randomised double-blinded controlled radiostereometry trial with 24 months of follow-up.Knee surgery, sports traumatology, arthroscopy: official journal of the esska, 10.1002/ksa.12753.Advance online publication.Https://doi.Org/10.1002/ksa.12753.H6: component code: mechanical (g04) - femur.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental report will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d1; d2; d4; g1; g3; g6; h1; h2; h3; h6; h10 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: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23434682
• Report Number: 3007963827-2025-00427
• Device Sequence Number: 14648163
• Product Code: MBH
• UDI-Device Identifier: 00889024230415
• UDI-Public: (01)00889024230415(17)280531(10)63946132
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: Lay User/Patient
• Device Catalogue Number: 42502606801
• Device Lot Number: 63946132
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 85 KG