MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT SPLINED KNEE STM 18X80; PROSTHESIS, KNEE

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Complaint sample was evaluated and the reported event was confirmed.Product evaluations stated, "visual inspection determined that there was no sterile indicator dot on the outside of the package as reported.Review of work instructions and inspection criteria determined that this product was non-conforming when it left zimmer biomet control." dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Investigation results concluded that the reported event was determined to be operator error.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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that when the part was received by the gscc there was no steridot on the outside of the box.There was no patient involvement.

• Brand Name: BMT SPLINED KNEE STM 18X80
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6950967
• MDR Text Key: 90336059
• Report Number: 0001825034-2017-08747
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PK121149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• 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: 141618
• Device Lot Number: 717840
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• 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