MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMER BLADE WITH PILOT HOLE 41MM; PROSTHESIS, KNEE

Catalog Number 00597909541

Device Problem Difficult to Insert (1316)

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

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: patella reamer shaft, catalog # 00512007741, lot # 56153800.(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 during a knee arthroplasty, the instrument would not assemble to the reamer guide.Subsequently, another instrument was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination indicates that the device exhibits signs of use.Dimensional evaluation indicates that the device conforms to the measurable print specifications.Dhr was reviewed and no discrepancies relevant to the reported event were found.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: PATELLA REAMER BLADE WITH PILOT HOLE 41MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7948842
• MDR Text Key: 123412936
• Report Number: 0001822565-2018-05577
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 04/12/2019

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: 00597909541
• Device Lot Number: 63961692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1