MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SHORT ANCHOR PLUG 10MM; PROSTHESIS, KNEE

Catalog Number	178552
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent an initial knee arthroplasty.Subsequently, the patient complained of pain over a span of the last year.The surgeon believed the expandable component was expanding on its own, without the required surgery to expand it.The patient felt a pop and could not bear wear.The patient was then revised approximately 3 years post implantation due to a broken anchor plug and the spindle lost bone in-growth at the bone interface and was no longer fixed.
Additional Manufacturer Narrative
(b)(4).D6: implant date: 2022.D10: concomitant medical products: cp114831 - rs side exp dstl fmrl lt - (b)(6).178363 - cps xs sht spdl w pins - (b)(6).178526 - cps transverse pin - (b)(6).161035 - oss rs axle - (b)(6).161034 - oss rs poly fem bushing - (b)(6).161037 - oss rs non-mod plate - (b)(6).150476 - oss poly tibial bushing - (b)(6).161094 - oss rs 12mm ls tibial bearing - (b)(6).150493 - oss reinforced yoke - (b)(6).150478 - oss poly lock pin - (b)(6).178512 - cps nut co-cr-mo alloy - (b)(6).H6: component code: mechanical (g04) - femur.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: on the later image, there are increased radiolucent lines at the compress spindle metal bone interface, consistent with the reported unfixed (loose) spindle.Also on the later image, the long axis of the exposed anchor plug traction bar is no longer parallel to the spindle but rather has a slight tilt which is a finding consistent with a broken traction bar.The segmental distal femur component has moved down exposing a greater length of the expander section on the later image.Reported event was confirmed by review of provided radiographs.Root cause was unable to 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 at time of this report.

• Brand Name: CPS SHORT ANCHOR PLUG 10MM
• 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: 23010320
• Report Number: 0001825034-2025-02853
• Device Sequence Number: 9796213
• Product Code: KWA
• UDI-Device Identifier: 00880304461659
• UDI-Public: (01)00880304461659(17)311216(10)952730
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 178552
• Device Lot Number: 952730
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 16 YR
• Patient Sex: Female