MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS TRANSVERSE PIN 6PK 28MM; PROSTHESIS, KNEE

Catalog Number	178526
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 - 270650 178363 - cps xs sht spdl w pins - 235950 178552 - cps short anchor plug - 952730 161035 - oss rs axle - 538210 161034 - oss rs poly fem bushing - 738370 161037 - oss rs non mod plate - 589350 150476 - oss poly tibial bushing - 148090 161094 - oss rs 12mm ls tibial bearing - 622880 150493 - oss reinforced yoke - 827180 150478 - oss poly lock pin - 148110 178512 - cps nut co-cr-mo alloy - 144930 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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2.Upon reassessment of the reported event, it has been determined that the device did not cause or contribute to the reported event.The initial report should be voided.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.

• Brand Name: CPS TRANSVERSE PIN 6PK 28MM
• 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: 23010307
• Report Number: 0001825034-2025-02852
• Device Sequence Number: 9848627
• Product Code: KWA
• UDI-Device Identifier: 00880304260511
• UDI-Public: (01)00880304260511(17)290121(10)297740
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 178526
• Device Lot Number: 297740
• 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: 01/13/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Female