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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A35; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A35; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number 5554L350
Device Problems Mechanical Problem (1384); Noise, Audible (3273)
Patient Problems Unspecified Infection (1930); Pain (1994); Injury (2348)
Event Date 05/13/2019
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
 
Event Description
It was reported that the patient's left knee was revised.As reported by rep, "patient complains of anterior knee pain and clicking." an office visit note reports "i strongly suspect a mechanical problem, namely excessive polyethylene wear from probably the metal back patellar component." the patellar device and insert were revised.Rep provided operative reports, implant reports, pre-revision x-rays and an explant picture, and reported that no further information is available.
 
Manufacturer Narrative
An event regarding crack/fracture involving a triathlon patella was provided.The event was confirmed following review of photographs provided.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted 5554l350 which was fractured - nothing else remarkable could be detected from the provided photograph.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: "deemed insufficient for medical review [.]: need medical records for patient's (b)(6) 2014 procedure.".-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, serial x-rays, revision operative reports as well as clinical and past medical history are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that the patient's left knee was revised.As reported by rep, "patient complains of anterior knee pain and clicking." an office visit note reports "i strongly suspect a mechanical problem, namely excessive polyethylene wear from probably the metal back patellar component." the patellar device and insert were revised.Rep provided operative reports, implant reports, pre-revision x-rays and an explant picture, and reported that no further information is available.
 
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Brand Name
TRIATHLON MB PATELLA PA A35
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8675563
MDR Text Key147218042
Report Number0002249697-2019-02185
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327049909
UDI-Public07613327049909
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2017
Device Catalogue Number5554L350
Device Lot NumberS94LK
Was Device Available for Evaluation? No
Date Manufacturer Received06/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
Patient Weight94
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