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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS AVL TIBIAL LOCK RING PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. OSS AVL TIBIAL LOCK RING PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
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: 0001825034-2021-01279, 0001825034-2021-01280, 0001825034-2021-01281, 0001825034-2021-01282, 0001825034-2021-01283, 0001825034-2021-01284. Medical product: 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 avl poly tib bushing set item# 161071 lot# 490920; 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 TIBIAL LOCK RING
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 Key11739283
MDR Text Key248817157
Report Number0001825034-2021-01278
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 Number161073
Device Lot Number466660
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? Device Not Returned to Manufacturer
Date Device Manufactured01/16/2019
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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