MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS BOW COLLARED STEM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the distributor the product arrived damaged with sterility barrier potentially compromised.There was no patient involvement.

Manufacturer Narrative

(b)(4).Investigation of the product determined the sterility of the product in the inner package is not compromised.This event is now determined to be not reportable.The initial report should be voided.

Event Description

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

• Brand Name: OSS BOW COLLARED STEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8496845
• MDR Text Key: 141373496
• Report Number: 0001825034-2019-01649
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K002757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• 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: 150488
• Device Lot Number: 600360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1