Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL LOCKING SCREW SET; PROSTHESIS, KNEE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL LOCKING SCREW SET; 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 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 5cm reinforced yolk catalog #: 150493 lot #: 065310, 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 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, 0001825034-2019-00701, 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.
 
Event Description
No further event information available at the time of this report.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL LOCKING SCREW SET
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8348422
MDR Text Key136496404
Report Number0001825034-2019-00705
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K020045
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number150481
Device Lot Number583850
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/28/2019
Initial Date FDA Received02/18/2019
Supplement Dates Manufacturer Received11/12/2019
Supplement Dates FDA Received11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight61
-
-