MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #1 RM/LL -8MM; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number 5630-G-128

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/28/2014

Event Type  Injury  

Event Description

It was reported that patient complained of pain which resulted in knee revision.

Manufacturer Narrative

Catalog number is unknown at this time.The device was reported as an unknown liner.Additional devices listed in this report: cat 5610-f-202 tri pkr femur#2 rm/ll lot code unknown.Cat 5620-b-102 tri pkr baseplate #1 rm/ll lot code wda1a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the devices are not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report.

Manufacturer Narrative

Based on the provided information, the product reported in this investigation did not contribute to the event.The event description indicated the baseplate was loose.No additional allegations were reported against the remaining devices.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that patient complained of pain which resulted in knee revision.

Manufacturer Narrative

Conclusion: based on the provided information, the product reported in this investigation did not contribute to the event.The event description indicated the baseplate was loose.No additional allegations were reported against the remaining devices.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that patient complained of pain which resulted in knee revision.

• Brand Name: TRIATHLON PKR INSERT X3 #1 RM/LL -8MM
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3875339
• MDR Text Key: 4511519
• Report Number: 0002249697-2014-02318
• Device Sequence Number: 1
• Product Code: NPJ
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 5630-G-128
• Device Lot Number: MLNE57
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2012
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 74