MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR FEMUR #3 RM/LL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5610-F-302

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

The following other device was also listed in this report: triathlon pkr baseplate #2 rm/ll; cat# 5620-b-202; lot# unknown.When completed, the investigation results will be submitted in a supplemental report.

Event Description

Per sales rep, a conversion from unicompartmental to a total knee arthroplasty (right).

Manufacturer Narrative

Corrected data: the device was not returned.An event regarding revision involving an triathlon femoral component was reported.The event was not confirmed.Method and results: device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: no medical records were provided for review with a clinical consultant.Conclusions: neither the event could be confirmed nor the root cause could be determined as the provided information was not sufficient.Further information such as device details, return of device, pathology reports, operative reports, xrays, patient history and follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

Per sales rep, a conversion from unicompartmental to a total knee arthroplasty (right).

• Brand Name: TRIATHLON PKR FEMUR #3 RM/LL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6048539
• MDR Text Key: 58132780
• Report Number: 0002249697-2016-03315
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082567
• 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: 12/29/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 5610-F-302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 39 YR