MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LPS ARTSURF PROV CD3-4/YEL 10; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the returned product identified signs of repeated use (nicked/gouged).The device was found to be fractured with all pieces returning.Review of the device history records identified no deviations or anomalies during manufacturing.Insufficient information provided to perform a compatibility check.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The device has a potential field age of over 21 years and exhibit signs of repeated use.Complaint is confirmed.The root cause of the reported event is attributed to wear and tear from repeated use over time.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

Event Description

It was reported the poly trial broke during range of motion test.No pieces fell into the patient.All pieces were accounted for.No patient impact.

• Brand Name: LPS ARTSURF PROV CD3-4/YEL 10
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15690690
• MDR Text Key: 303563166
• Report Number: 0001822565-2022-03041
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00599703010
• Device Lot Number: 71396300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 109 KG