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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI LM/RL TIB AUG SZ4 5MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
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STRYKER ORTHOPAEDICS-MAHWAH TRI LM/RL TIB AUG SZ4 5MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS Back to Search Results
Catalog Number 5545-A-401
Device Problems Inadequacy of Device Shape and/or Size (1583); Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2015
Event Type  malfunction  
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
Event Description
It was reported that during a zimmer left total knee revision, surgeon went to implant the tibial augment and noticed a size discrepancy immediately - surgeon noticed overhang which confirmed the size discrepancy.Device was labeled as a sz 4 on the device, packaging, labeling etc.But augment was bigger closer to a size 6.
 
Manufacturer Narrative
An event regarding an oversized size 4 triathlon augment was reported.The event was confirmed.Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot.Visual inspection: the device was returned and appears to be in new condition.Visually the device is unremarkable.Dimensional inspection : the device was run on cmm ma-10980.As part of the inspection process, a cmm program is ran in order to measure the device features.The program will start once it is able to detect features unique to the size of the device, which the program uses as an origin point.The cmm was unable to run under the measurement of the size 4 program, 5545-a-401-1-buy_rev01, as it was unable to determine the origin features.The program for the device of the next size, part 5545-a-501 was then performed, in which the cmm passed the part as a size 5; therefore, confirming the event that the device is not a size 4 as marked, but a larger size.Review of the device markings indicated that device is a size 4; however, dimensional inspection was performed and determined that the device was a size 5.
 
Event Description
It was reported that during a zimmer left total knee revision, surgeon went to implant the tibial augment and noticed a size discrepancy immediately - surgeon noticed overhang which confirmed the size discrepancy.Device was labeled as a sz 4 on the device, packaging, labeling etc.But augment was bigger closer to a size 6.
 
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Brand Name
TRI LM/RL TIB AUG SZ4 5MM
Type of Device
KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5063521
MDR Text Key25911169
Report Number0002249697-2015-02944
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2019
Device Catalogue Number5545-A-401
Device Lot NumberER9HH0D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/02/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age68 YR
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