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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS; 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).Concomitant medical devices ¿ orthopedic salvage system modular tibial baseplate 67mm, catalog #: 15042,1 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 5cm reinforced yolk, catalog #: 150493, lot #: 065310; orthopedic salvage system polyethylene tibial bushing, catalog #: 150476, lot #: 248130; 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, 0001825034-2019-00699, 0001825034-2019-00700, 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.Device evaluated by mfr? 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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies relevant to the reported event were identified.The root cause is attributed to the procedure performed with no device failure identified.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8348416
MDR Text Key136488584
Report Number0001825034-2019-00701
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K021260
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
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 Health Professional
Device Expiration Date08/31/2023
Device Model NumberN/A
Device Catalogue Number161034
Device Lot Number261210
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight61
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