MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FINN MODULAR TIBIAL STEM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Necrosis (1971)

Event Date 10/12/2000

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: finn modular tibial stem, cat#: 154085, lot#: 926600; intramedullary plug, cat#: 130611, lot#: 612600; finn modular resurfacing femoral, cat#: 153801, lot#: 274460; finn femoral bushing, cat#: 153852, lot#: 218720; finn locking pin, cat#: 153861, lot#: 182930; finn tibial bushing, cat#: 153851, lot#: 606870; finn axle, cat#: 153872, lot#: 663520; finn modular tibial bushing, cat#: 153982, lot#: 940040; finn reinforced yoke, cat#: 153865, lot#: 949890; finn modular tibial base, cat#: 154083, lot#: 533040.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-07408, 0001825034-2017-07409, 0001825034-2017-07412, 0001825034-2017-07413, 0001825034-2017-07414, 0001825034-2017-07415, 0001825034-2017-07416, 0001825034-2017-07417, 0001825034-2017-07418, 0001825034-2017-07419.Remains implanted.

Event Description

It was reported that the patient had undergone an irrigation and debridement due to drainage and fluid collection.Necrosis was also noted during the debridement.No additional patient consequences were reported.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: FINN MODULAR TIBIAL STEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6907307
• MDR Text Key: 87969726
• Report Number: 0001825034-2017-07410
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: PK945028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 153815
• Device Lot Number: 352710
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 77