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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM YOKE; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM YOKE; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Neuropathy (1983); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant devices ¿ orthopedic salvage system femoral bushings catalog #: 150477 lot #: 250110, orthopedic salvage system porous coated straight im stem 16.5mm x 150mm catalog #: 150451 lot #: 785670, biomet suture button single ¼ inch peg with wire 37mm x 10mm catalog #: 11-150863 lot #: 156460, orthopedic salvage system resurfacing porous coated femoral component 5cm right catalog #: 150352 lot #: 121720, orthopedic salvage system locking pin catalog #: 150478 lot #: 233570, orthopedic salvage system 71mm modular tibial base with plug catalog #: 150422 lot #: 140340, orthopedic salvage system tibial bushing catalog #: 150476 lot #: 180710, orthopedic salvage system porous coated im stem with screw 14.5mm x 90mm, orthopedic salvage system 22mm tibial bearing catalog #: 150415 lot #: 982670, orthopedic salvage system axle catalog #: 150480 lot #: 407180, vanguard series a standard patella 37mm x 10mm catalog #: 184768 lot #: 533400.It is indicated by the complainant that the devices will not be returned to zimmer biomet for investigation, as the devices currently remain 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 event; please see all reports associated with this event.0001825034-2018-08263; 0001825034-2018-08264; 0001825034-2018-08265; 0001825034-2018-08266; 0001825034-2018-08267; 0001825034-2018-08268; 0001825034-2018-08269; 0001825034-2018-08270; 0001825034-2018-08271; 0001825034-2018-08272; 0001825034-2018-08273; 0001825034-2018-08274.Device remains implanted.
 
Event Description
It is reported that the patient is experiencing post-operative pain, neuropathy, several reports of falling and issues with range of motion approximately three (3) years following right knee arthroplasty.No additional patient consequences were reported.
 
Event Description
It is reported that the patient is experiencing post-operative pain, neuropathy, several reports of falling and issues with range of motion approximately three (3) years following right knee arthroplasty.The patient has enrolled in additional physical therapy to address these complications.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 radiographic inspection, however, the reported event was not confirmed.The device history records were reviewed and no discrepancies relevant to the reported event were identified.Although it is reported that the patient had fallen on multiple occasions and refused to wear a knee brace for stability, a definitive root cause could not be determined with the information provided.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.
 
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Brand Name
ORTHOPEDIC SALVAGE SYSTEM YOKE
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7797071
MDR Text Key117586493
Report Number0001825034-2018-08267
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
PK052685
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number150493
Device Lot Number122870 
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Weight91
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