MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC; KNEE INSTRUMENT

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Reporter had indicated that product will be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the stain was found on the inner package of the sterile packaging during inspection.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device confirmed there is a stain on the cavity lid right above the label.There were no stains or damaged to the outer box.The sterile barrier was not breached.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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 event information available at the time of this report.

• Brand Name: TAPERLOC
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7476118
• MDR Text Key: 107360246
• Report Number: 0001825034-2018-03016
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PK101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: N/A
• Device Catalogue Number: 51-103110
• Device Lot Number: 6201077
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 04/13/2018; 12/11/2018
• Supplement Dates FDA Received: 05/08/2018; 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1