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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number 5510F502
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Loss of Range of Motion (2032); Injury (2348)
Event Date 05/01/2017
Event Type  Injury  
Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department. 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.

 
Event Description

It was reported that allegedly the patient was revised due to "pre-op findings: 1. Arthrofibrosis after right total knee arthroplasty, index procedure (b)(6) 2016" and "post-op findings: 1. Pre-op motion 3-75; 2. Post-op motion 0-120; 3. Partially loose femoral component; 4. Partially loose tibial component (medial side); 5. Retained patellar component".

 
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Brand NameTRIATHLON CR FEM COMP #5 R-CEM
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8421190
MDR Text Key138809520
Report Number0002249697-2019-01333
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 03/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2020
Device Catalogue Number5510F502
Device LOT NumberAK76K
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/07/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/14/2019 Patient Sequence Number: 1
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