MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE SYSTEM FEMORAL FINISHING GUIDE LEFT MEDIAL; INSTRUMENT, KNEE

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).It is unknown if product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation is completed, a follow-up report will be filed accordingly.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.Product location unknown.

Event Description

It was reported that medial femoral cutting guide was bent when sawblade was used to cut sawbone.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

(b)(4).D4: udi # (b)(4).Reinvestigation does not change the previous root cause.Visual inspection of the returned product found that the device is bent and also exhibits nicked / gouged / burrs.Root cause cannot be determined.The complaint is confirmed.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: PERSONA PARTIAL KNEE SYSTEM FEMORAL FINISHING GUIDE LEFT MEDIAL
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8519296
• MDR Text Key: 142220923
• Report Number: 0001825034-2019-01734
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2020

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 Model Number: N/A
• Device Catalogue Number: 42578100301
• Device Lot Number: 63517786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 09/18/2019; 06/09/2020
• Supplement Dates FDA Received: 09/23/2019; 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1