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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM 5CM REINFORCED YOLK PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM 5CM REINFORCED YOLK PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Date 12/07/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Udi #: (b)(4). Concomitant medical devices: orthopedic salvage system modular tibial baseplate 67mm catalog #: 150421 lot #: 523710, orthopedic salvage system tibial augment block 10 x 63/67mm catalog #: 150426 lot #: 225600, orthopedic salvage system cemented proximal tibial stem catalog #: 150445 lot #: 751190, orthopedic salvage system polyethylene tibial bushing catalog #: 150476 lot #: 248130, orthopedic salvage system rs polyethylene femoral bushings catalog #: 161034 lot #: 261210, orthopedic salvage system rs axle catalog #: 161035 lot #: 257570, orthopedic salvage system polyethylene locking pin catalog #: 150510 lot #: 211820, orthopedic salvage system cemented im stem 13mm x 225mm catalog #: 150374 lot #: 416160, orthopedic salvage system diaphyseal locking screw set catalog #: 150481 lot #: 583850, orthopedic salvage system 4cm diaphyseal segment catalog #: 150482 lot #: 034700, orthopedic salvage system segmental stacking adapter catalog #: 150483 lot #: 097170, orthopedic salvage system 4cm diaphyseal segment catalog #: 150482 lot #: 899920, orthopedic salvage system rs 7cm modular segmented femoral component right catalog #: 161011 lot #: 306670, orthopedic salvage system polyethylene tibial bearing 16mm catalog #: 150412 lot #: 790410. The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as it still remains implanted. 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: 0001825034-2019-00696, 0001825034-2019-00697, 0001825034-2019-00698, 0001825034-2019-00700, 0001825034-2019-00701, 0001825034-2019-00702, 0001825034-2019-00703, 0001825034-2019-00704, 0001825034-2019-00705, 0001825034-2019-00706, 0001825034-2019-00707, 0001825034-2019-00708, 0001825034-2019-00709, 0001825034-2019-00710. Investigation incomplete.
 
Event Description
It is reported that during the patient¿s post-operative stay for knee arthroplasty, the patient experienced low hemoglobin and hematocrit levels and required a blood transfusion for post-operative anemia. No additional patient consequences were reported.
 
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Brand NameORTHOPEDIC SALVAGE SYSTEM 5CM REINFORCED YOLK
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 Key8348419
MDR Text Key136481549
Report Number0001825034-2019-00699
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052685
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number150493
Device Lot Number065310
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 Received11/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2018
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: 02/18/2019 Patient Sequence Number: 1
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