MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMER BLADE 26MM; PROSTHESIS, KNEE

Catalog Number 00597909526

Device Problem Difficult to Insert (1316)

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

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign source- (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patella reamer blade would not assemble with the mating instrument.No adverse events have been reported as a result of the malfunction.

Event Description

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

Manufacturer Narrative

Concomitant medical products: catalog# 00597909526 patella reamer blade with pilot hole lot# 64153510, catalog# 00512007026 patella reamer insetting guide with coating lot# ni.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event 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.

• Brand Name: PATELLA REAMER BLADE 26MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8218367
• MDR Text Key: 132222227
• Report Number: 0001822565-2018-07088
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

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: Health Professional
• Device Catalogue Number: 00597909526
• Device Lot Number: 63980089
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1