MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEG DIST FEM SIZE C LT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products:: unknown tibial tray; unknown tibial bearing.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that device has had repeated failure of the coupling mechanism (lock break).Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.The device history record was reviewed and no discrepancies relevant to the reported event were found.Per the segmental system package insert, fracture/damage of the prosthetic knee components is a known potential adverse effect of this procedure.A definitive root cause 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 event information available at the time of this report.

• Brand Name: SEG DIST FEM SIZE C LT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8883672
• MDR Text Key: 153996618
• Report Number: 0001822565-2019-03425
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• 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: 00585004301
• Device Lot Number: 64178771
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 83 YR