MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS CENTERING SLEEVE 13MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was repprted the traction bar of compress anchor plug fractured while placing compression nut.Centering sleeve fracture noted as well.No known patient impact.
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmerbiomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 178552 cps short anchor plug 10mm lot# 148700.Mdr: 0001825034-2023-00075.Additional associated products: 178366 cps sm sht spdl w pins 600lbf lot# 567750, 178512 cps nut co-cr-mo alloy lot# 278090.
Additional Manufacturer Narrative
Upon receiving additional information found during investigation of the reported event, it was determined that the part referenced should not have been reported.The part referenced was not fractured and had no claim against it.The initial report should be voided.
Event or Problem Description
Upon receiving additional information found during investigation of the reported event, it was determined that the part referenced should not have been reported.The part referenced was not fractured and had no claim against it.The initial report should be voided.

• Brand Name: CPS CENTERING SLEEVE 13MM
• 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: 16151783
• Report Number: 0001825034-2023-00076
• Device Sequence Number: 20584366
• Product Code: JDI
• UDI-Device Identifier: 00880304260603
• UDI-Public: (01)00880304260603(17)271003(10)902960
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K031804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178535
• Device Lot Number: 567750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose