MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS XS SHT SPDL W PINS 600LBF; PROSTHESIS, KNEE

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02569.

Event Description

It was reported that the patient underwent a revision approximately 7 years post implantation due to a failed spindle/anchor plug connection.It was noted that they never saw a centralizer cone come out of the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

Event Description

It was determined that only anchor plug was fractured.The returned short spindle only shows sign of use and no other damages.Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: CPS XS SHT SPDL W PINS 600LBF
• Type of Device: 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: 18055630
• MDR Text Key: 327164902
• Report Number: 0001825034-2023-02568
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 178363
• Device Lot Number: 845250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female