MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F402

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Edema (1820); Injury (2348)

Event Date 02/25/2016

Event Type  Injury  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

Cyst on femur.Replaced triathlon components with gmrs/mrh components.

Manufacturer Narrative

An event regarding cyst on femur resulting in revision surgery involving a triathlon femoral component was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection of the returned femoral component has bone cement still adhered to the inferior surface with evidence of bone ingrowth throughout.There is also a peg-like formation of cement which would indicate a void was present in the femur into which the bone cement filled.The superior condyle surfaces have some mild abrasive wear that is consistent with in vivo use as well as some explantation damage.The device is otherwise unremarkable.Medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.Post event x-rays would be required to probably solve this case.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusion: it is reported that the patient had a cyst on the femur and revision surgery took place whereby the reported triathlon devices were revised to a gmrs/mrh knee system.The exact cause of the event could not be determined as insufficient information was provided.Further information such as post event x-rays are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Cyst on femur.Replaced triathlon components with gmrs/mrh components.

• Brand Name: TRIATHLON CR FEM COMP #4 R-CEM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NJ NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5508342
• MDR Text Key: 40609534
• Report Number: 0002249697-2016-00903
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 5510F402
• Device Lot Number: SEAEH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR