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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM RS LS TIBIAL BEARING 20MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM RS LS TIBIAL BEARING 20MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Degraded (1153); Patient Device Interaction Problem (4001)
Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Date 02/07/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant devices: orthopedic salvage system reinforced yoke catalog #: 150493 lot #: 362040, orthopedic salvage system rs polyethylene femoral bushings catalog #: 161034 lot #: ni, orthopedic salvage system rs axle catalog #: 161035 lot #: ni, unknown orthopedic salvage system lock pin catalog #: ni lot #: ni, unknown orthopedic salvage system tibial bushing catalog #: ni lot #: ni, unknown orthopedic salvage system rs segmental distal femur catalog #: ni lot #: ni, unknown orthopedic salvage system rs non-modular tibia catalog #: ni lot #: ni. Report source: foreign: (b)(6). The complainant has not yet indicated whether the product will 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. Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2022-00354, 0001825034-2022-00355.
 
Event Description
It was reported that the patient underwent a knee arthroplasty revision to address post-operative fracture of the yoke, damage to the tibial bearing, pain and difficulty ambulating approximately one (1) year post-operatively. Attempts have been made, however, no additional information is available.
 
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Brand NameORTHOPEDIC SALVAGE SYSTEM RS LS TIBIAL BEARING 20MM
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 Key13548452
MDR Text Key285735046
Report Number0001825034-2022-00355
Device Sequence Number1
Product Code KRO
UDI-Device Identifier00880304554719
UDI-Public(01)00880304554719(17)240402(10)967760
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K052685
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number161098
Device Lot Number967760
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2019
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: 02/17/2022 Patient Sequence Number: 1
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