MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE H 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer had indicated that the product was being returned to zimmer biomet for investigation, but it has not yet been received.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported articular surface provisional size 8mm, cracked when removing after final trialing.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual inspection of the returned provisional confirmed that the device was cracked and the devices exhibits signs of usage.The dhr was reviewed and no discrepancies relevant to the reported event were found.The device has been in the field for approximately two years and eleven months.It is unknown for how many times the device is being used.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE H 8 MM THICKNESS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10506979
• MDR Text Key: 206108658
• Report Number: 0001822565-2020-03171
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304810020
• UDI-Public: (01)00880304810020
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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: 42518100808
• Device Lot Number: 63791075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1