MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FINN TIBIAL BUSHING; 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 tibial stem, cat#: 153815 lot#: 352710 finn modular resurfacing femoral, cat#: 153801 lot#: 274460 finn femoral bushing, cat#: 153852 lot#: 218720 finn locking pin, cat#: 153861 lot#: 182930 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, 0001825034-2017-07410, 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 TIBIAL BUSHING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6907304
• MDR Text Key: 87992290
• Report Number: 0001825034-2017-07415
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: PK910877
• 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: 153851
• Device Lot Number: 606870
• 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