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

Model Number N/A

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problems Failure of Implant (1924); Cancer (3262)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 150465 - oss 5cm diaphyseal segment - 384970; 150354 - oss 7cm segmental femoral rt - 587020; 150493 - oss reinforced yoke - 602080; 150480 - oss axle - 516460; 150477 - oss poly femoral bushings - 790160; 150476 - oss poly tibial bushing - 967230; 150410 - oss tibial poly bearing 12mm - 050900; 150478 - oss poly lock pin - 090530.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an oss compress approximately 6 months ago.The surgical team was informed the patient had stopped his chemotherapy, however, at the patient's 2 month post-op appointment, it was noticed that rod from the anchor plug that connects to the spindle had bent and there was no new bone growth.The patient had continued his chemotherapy and the bar fractured and subsequently underwent a revision 2 months later.The surgeon cut just above the anchor plug in order to preserve the pins and bushings and also replaced the femoral component and diaphyseal segment.The tibial component was not revised.The surgical technique was utilized.There was no surgical delay.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6 visual examination of the provided pictures identified a fracture of the anchor plug from the spindle.The dhr was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fracture of the right knee distal femoral replacement implant.A definitive root cause cannot be determined.Per package insert, fracture is a known adverse effect of the system.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 Description

No further event information available at the time of this report.

• Brand Name: CPS SHORT ANCHOR PLUG 12MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11562603
• MDR Text Key: 242054330
• Report Number: 0001825034-2021-00861
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304461703
• UDI-Public: (01)00880304461703(17)291111(10)037980
• Combination Product (y/n): N
• PMA/PMN Number: K062998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178554
• Device Lot Number: 037980
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 81