MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN PATELLA REAMER WITH PILOT DRILL 38; PROSTHESIS, KNEE INSTRUMENT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint device will be returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a patient underwent an initial knee procedure on an unknown date.The patella reaming blade slipped off and patient received injury due to malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.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

It was also reported that a patient underwent an initial knee procedure on an unknown date.The patella reaming blade slipped off which resulted in increased reaming and thinned bone.No additional patient consequences were reported.

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.Dhr was reviewed and no discrepancies were found.The device had approximately 15 years of field life with unknown frequency of usage.The root cause can be considered to be wear due to normal usage.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: NEXGEN PATELLA REAMER WITH PILOT DRILL 38
• Type of Device: PROSTHESIS, KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6859181
• MDR Text Key: 85812084
• Report Number: 0001822565-2017-06312
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00597907738
• Device Lot Number: 56076600
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 09/28/2017; 04/12/2018
• Supplement Dates FDA Received: 10/24/2017; 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2002
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention