MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 4; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by manufacturer? not returned to manufacturer.

Event Description

It was reported foreign matter was identified in the device packaging prior to use.No further information available at the time of this reporting.

Manufacturer Narrative

- visual evaluation of the returned product identified that there is hair-like debris inside the sterile package.Both the sterile packagings have been opened when returned.The complaint has been confirmed by visual evaluation.- review of the device history records identified no related deviations or anomalies during manufacturing.- the likely condition of the product when it left zimmer biomet control cannot be determined.A definitive root cause of the reported event cannot be determined.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

No further information available at the time of this reporting.

• Brand Name: ARTICULATION KIT SIZE 4
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8655065
• MDR Text Key: 146532560
• Report Number: 0001822565-2019-02258
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• 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: 00840009400
• Device Lot Number: 64223161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1