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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS RS POLY FEM BUSHINGS SET/2; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. OSS RS POLY FEM BUSHINGS SET/2; PROSTHESIS, KNEE Back to Search Results
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  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2022-01862, 0001825034-2022-01863, 0001825034-2022-01865, 0001825034-2022-01866, 0001825034-2022-01867.Medical product: oss rs axle item# 161035 lot# 821880.Oss poly lock pin item# 150478 lot# 289470.Oss poly tibial bushing item# 150476 lot# 183060.Oss tibial poly bearing 20mm item# 150414 lot# 351350.Oss reinforced yoke item# 150493 lot# 529730.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 14mm item# 178404 lot# 136710.Cps transverse pin 6pk 36mm item# 178528 lot# 889380.Cps sm m-h f spindle 12mm pcha item# 178472 lot# 240530.Cps nut co-cr-mo alloy item# 178512 lot# 485340.Cps/oss 5cm tpr adapt w/oss sc item# 178711 lot# 821510.Oss rs 7 cm mod seg fmrl-lt item# 161012 lot# 547240.Cps centering sleeve 16mm item# 178538 lot# 818860.Cobalt mv bone cement 40gm 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.
 
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
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.
 
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.
 
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.
 
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Brand Name
OSS RS POLY FEM BUSHINGS SET/2
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 Key15257729
MDR Text Key298206816
Report Number0001825034-2022-01864
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021260
Number of Events Reported1
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 Received08/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/28/2015
Device Model NumberN/A
Device Catalogue Number161034
Device Lot Number838700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/21/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10
Patient Outcome(s) Other;
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