MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET OFFSET TIBIAL TRAY ADAPTOR; PROSTHESIS KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products - arcom series a patella standard # 184764 lot # 535310 , biomet offset tibial tray # 141482 lot # 744940, vanguard ps tibial bearing # 183624 lot # 653110, biomet smooth knee stem # 145024 lot # 574960.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-10674, 0001825034-2017-10675, 0001825034-2017-10676 and 0001825034-2017-10677.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was experiencing pain and loss of sensation in his left knee post a revision surgery.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable as this product was not related to the patella fracture and pain of the patient.

• Brand Name: BIOMET OFFSET TIBIAL TRAY ADAPTOR
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7068700
• MDR Text Key: 93286969
• Report Number: 0001825034-2017-10678
• Device Sequence Number: 1
• Product Code: MBV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK010212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 141491
• Device Lot Number: 470640
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 78