MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS REINFORCED YOKE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that a patient is being considered for a revision to replace poly components due to unknown reasons.Attempts to obtain additional information have been made; however, no more information is available at this time.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2022-01862, 0001825034-2022-01863, 0001825034-2022-01864, 0001825034-2022-01865, 0001825034-2022-01866.Medical product: oss rs axle, item# 161035, lot# 821880.Oss poly lock pin, item# 150478, lot# 289470.Oss rs poly fem bushings set/2, item# 161034, lot# 838700.Oss poly tibial bushing, item# 150476, lot# 183060.Oss tibial poly bearing 20 mm, item# 150414, lot# 351350.Oss tib block 20x63/67 ml/lr, item# 150430, lot# 246240.Oss tib blk aug 10x63/67 univ, item# 150426, lot# 626690.Cps anchor plug 14 mm, item# 178404, lot# 136710.Cps transverse pin 6 pk 36 mm, item# 178528, lot# 889380.Cps sm m-h f spindle 12 mm pcha, item# 178472, lot# 240530.Cps nut co-cr-mo alloy, item# 178512, lot# 485340.Cps/oss 5 cm tpr adapt w/oss sc, item# 178711, lot# 821510.Oss rs 7 cm mod seg fmrl-lt, item# 161012.Lot# 547240.Cps centering sleeve 16 mm, item# 178538.Lot# 818860.Cobalt mv bone cement 40 gm b, item# 402439, lot# 187910.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.

Event Description

It was reported that patient was complaining of lack of knee stability.Surgeon shared his input that he believed the tibia bushing components had begun to fail based on x-rays of the knee joint and location of axle relative to the tibia body through hole that housed the bushings.Attempts to obtain additional information have been made; however, no more information is available.

Event Description

Upon receipt of additional information, it was determined that this item was reported in error.The initial report was submitted in error and should be voided.Additional information received indicates that only the custom tibial bushings were worn.

Manufacturer Narrative

Upon receipt of additional information, it was determined that this item was reported in error.The initial report was submitted in error and should be voided.Additional information received indicates that only the custom tibial bushings were worn.

• Brand Name: OSS REINFORCED YOKE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15257754
• MDR Text Key: 298203124
• Report Number: 0001825034-2022-01867
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 150493
• Device Lot Number: 529730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2010
• 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