MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS ANCHOR PLUG 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient felt a pain around one month post revision.Visited the hcp for examination early may and the x-rays showed shortening between the anchor plug and spindle as in the previous visit.No revision has taken place at this time.
Additional Manufacturer Narrative
(b)(4).G2: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products(reported).(b)(4) cps sm spdl with pins 600lbf lot# 981260.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h10, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no related deviations or anomalies during manufacturing.Insufficient information to perform compatibility check.X-ray review by third party hcp states that there is interval progressive decrease in the oss implant anchor plug-spindle distance and progressive backing out of a distal femoral screw with increasing periosteal new bone formation along the distal femur as noted.Complaint is confirmed via x-ray evaluation.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental 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: CPS ANCHOR PLUG 12MM
• 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: 19491880
• Report Number: 0001825034-2024-01508
• Device Sequence Number: 7107307
• Product Code: JDI
• UDI-Device Identifier: 00880304259713
• UDI-Public: (01)00880304259713(17)330725(10)497110
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 11/25/2024

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: 178402
• Device Lot Number: 497110
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 79 KG