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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.
 
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Brand NameOSS AVL POLY TIB BUSHING SET
Type of DevicePROSTHESIS, 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 Key11739345
MDR Text Key247779384
Report Number0001825034-2021-01283
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Reporter Occupation
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
Device Model NumberN/A
Device Catalogue Number161071
Device Lot Number490920
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/07/2018
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 Treatment Data
Date Received: 04/28/2021 Patient Sequence Number: 1
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