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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE1 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE1 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number 5531-G-109
Medical Device Problem Code Unstable (1667)
Health Effect - Clinical Code Ambulation or Postural Difficulties (2544)
Date of Event 04/06/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event or Problem Description
It was reported that the patient's right knee was revised due to pain and instability.A 1 x 9 poly insert was swapped for a 1 x 11 poly insert.Rep confirmed that no further information would be released by the hospital or surgeon.
 
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Brand Name
X3 TRIATHLON CS INS SIZE1 9MM
Common Device Name
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key11752062
Report Number0002249697-2021-00761
Device Sequence Number4244352
Product Code MBH
UDI-Device Identifier07613327045581
UDI-Public07613327045581
Combination Product (Y/N)N
Initial Reporter StateRI
Initial Reporter CountryUS
PMA/510(K) Number
K141056
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/30/2021
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
Operator of Device Health Professional
Device Model Number5531-G-109
Device Catalogue Number5531G109
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/06/2021
Initial Report FDA Received Date04/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age49 YR
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