MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT POROUS SIZE F RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: patella reamer blade with pilot hole, catalog #: 00597909535, lot #: 54067300, trabecular metal ps tibial, catalog #: 00588605614, lot #: 6037644, nexgen tm standard patella, catalog #: 00587806535, lot #: 60448090.Customer has indicated product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.When the investigation is complete, a follow-up report will be submitted.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.Device remains implanted in patient.

Event Description

It was reported patient underwent right total knee arthroplasty.Subsequently, patient experienced a burning in his knee since 9 months post-op.Patient also reports loosening of the muscles, causing knee to be loose.There is a continuous burning that affects of the leg muscles, going up into buttocks and now affecting the patient's chest and arm.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.No product or medical records received.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.

• Brand Name: FEMORAL COMPONENT POROUS SIZE F RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8152120
• MDR Text Key: 129951896
• Report Number: 0001822565-2018-06844
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K031061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: N/A
• Device Catalogue Number: 00599201602
• Device Lot Number: 60407124
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 102