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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS AVL POLY TIB BUSHING SET; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. OSS AVL POLY TIB BUSHING SET; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 08/14/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-01278, 0001825034-2021-01279, 0001825034-2021-01280, 0001825034-2021-01281, 0001825034-2021-01282, 0001825034-2021-01284.Medical product: oss avl tibial lock ring, item# 161073, lot# 466660.Oss avl yoke 12mm, item# 161075 lot# 382130.Oss avl mod tib plate oss tape, item# 161065, lot# 690080.Oss avl tib bearing 12mm, item# 161068, lot# 809890.Oss tib blk aug 10x63/67 univ, item# 150426, lot# 105590.Oss poly femoral bushings, item# 150477, lot# 499870.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 was revised approximately five months¿ post-implantation due to locking nut fractured in two pieces and allowed piston to disengage from the tibial component.Attempts to obtain additional information have been made; however, no more information is available.
 
Manufacturer Narrative
Upon further investigation, it was determined that this item was reported in error.The locking ring fracture is what caused the yoke to disassociate from the tibial tray.Therefore, the locking ring is the only reportable item.The initial report was submitted in error and should be voided.
 
Event Description
Upon further investigation, it was determined that this item was reported in error.The locking ring fracture is what caused the yoke to disassociate from the tibial tray.Therefore, the locking ring is the only reportable item.The initial report was submitted in error and should be voided.
 
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Brand Name
OSS AVL POLY TIB BUSHING SET
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11739345
MDR Text Key247779384
Report Number0001825034-2021-01283
Device Sequence Number1
Product Code KRO
UDI-Device Identifier00880304456174
UDI-Public(01)00880304456174(17)230107(10)490920
Combination Product (y/n)N
PMA/PMN Number
K051570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Type of Report Initial,Followup
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/07/2023
Device Model NumberN/A
Device Catalogue Number161071
Device Lot Number490920
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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