MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #5 RM/LL -12MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5630-G-522

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Poly failed to lock into the baseplate.

Manufacturer Narrative

An event regarding difficulty seating a triathlon pkr insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the exact cause of the event could not be determined because the device was not returned for analysis.No further investigation for this event is possible at this time as no devices and/or insufficient information was received.If devices and/or additional information become available, this investigation will be reopened.Corrected data: the device was not available for evaluation.

Event Description

Poly failed to lock into the baseplate.

• Brand Name: TRIATHLON PKR INSERT X3 #5 RM/LL -12MM
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5483796
• MDR Text Key: 39790901
• Report Number: 0002249697-2016-00705
• 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: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 5630-G-522
• Device Lot Number: MLMXV5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 03/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2012
• 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): Other
• Patient Age: 32 YR
• Patient Weight: 91