MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRESS ANCHOR PLUG 14MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical devices: transdermal compress spindle st 38mm 800lb catalog#: 110045692 lot#: rm2665.Cps transverse pin 6pk 28mm catalog#: 178526 lot#: 65985249.Cps centering sleeve 16mm catalog#: 178538 lot#: 609310.Cps nut co-cr-mo alloy catalog#: 178512 lot#: 65766784.Trnsdrm cmp spndl plug catalog#: 110045695 lot#: rm033t.Trnsdrm cmp osti spdl clr 38mm catalog#: 110045681 lot#: rm590t.Trnsdrm cmp adptr size 2 catalog#: 110045676 lot#: rm027t.Trnsdrm cmp adptr plug catalog#: 110045679 lot#: rm031t.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported via ide study that a patient underwent a knee procedure.Subsequently, patient was revised approximately four months later due to pain and loosening.It was noted intra-operatively that the anchor plug was no longer attached to the spindle.No further information has been provided at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, e1, e2, e3, g1, g2, g3, g6, h1, h2, and h11.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, and h11 no product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Revision notes provided state that the patient underwent revision surgery for device loosening during the surgery they found that the anchor plug was no longer attached to the spindle.The anchor plug and distal threads appeared to be completely intact.The bone was much thicker and more robust than upon implant.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint is confirmed via medical records provided.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue.To monitor for trends.

• Brand Name: COMPRESS ANCHOR PLUG 14MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20908217
• Report Number: 0001825034-2024-02918
• Device Sequence Number: 12872530
• Product Code: KRO
• UDI-Device Identifier: 00880304002890
• UDI-Public: (01)00880304002890(17)330727(10)65720776
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K043547
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178404
• Device Lot Number: 65720776
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 12/30/2024; 04/08/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/16/2025; 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 79 KG