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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E PROSTHESIS, KNEE

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ZIMMER, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 12/07/2016
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: persona femur trabecular metal posterior stabilized (ps) narrow porous left catalog# 42500206201 lot# 62561635, persona articular surface catalog# 42511400711 lot# 62747270, patella catalog# 00587806532 lot# 62756941.
 
Event Description
It was reported that the patient has subsidence. However, no revision has been reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. The physician assessment of postop radiographs stated the following: - no intraoperative adverse event reported. - no significant radiographic findings were reported from six-week post-surgery x-ray images. - radiolucency was identified on x-ray images six months post-surgery. - a 1mm circumferential gap was identified on x-ray images one year post-surgery. - subsidence and radiolucency were identified on x-ray images two years post-surgery. There were no x-ray or clinical changes, no pain or symptoms in the left knee. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. The investigation determined that the likely root causes for the higher than anticipated complaint rate are that the persona tm tibia allows the potential for the tibial implant to sit proud on the resected tibial surface and the persona tm tibia has less initial stability than predicate devices. Therefore, the problem with this device constitutes a "design issue" as the root cause. 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
It was reported that the patient has tibial subsidence. However, no revision has been reported.
 
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Brand NameNATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6251863
MDR Text Key64882537
Report Number0001822565-2017-00223
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42530007101
Device Lot Number62758492
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1266-2015

Patient Treatment Data
Date Received: 01/13/2017 Patient Sequence Number: 1
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