MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR FEMUR #2 RM/LL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5610-F-202

Device Problem Insufficient Information (3190)

Patient Problems Damage to Ligament(s) (1952); Injury (2348)

Event Date 05/17/2016

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: triathlon pkr baseplate #1 rm/ll; cat# 5620-b-102; lot# unknown.Triathlon pkr insert x3 #1 rm/ll -8mm; cat# 5630-g-128; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Loosening of the ligaments.Right knee.

• Brand Name: TRIATHLON PKR FEMUR #2 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5721029
• MDR Text Key: 47260232
• Report Number: 0002249697-2016-01932
• 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
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5610-F-202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR
• Patient Weight: 81