MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR BASEPLATE #3 LM/RL; IMPLANT

Catalog Number 5620-B-301

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 02/06/2015

Event Type  Injury  

Event Description

This patient is a subject in (b)(6) clinical study.The patient is experiencing tibial component loosening and is scheduled to have a revision to a total knee on (b)(6) 2015.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding loosening of a triathlon pk baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no devices were returned for inspection -medical records received and evaluation: insufficient patient medical records were provided for review.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the exact cause of the event could not be determined because insufficient patient information was provided for review and the device was not returned for evaluation.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

This patient is a subject in the triathlon pkr clinical study.The patient is experiencing tibial component loosening and is scheduled to have a revision to a total knee on (b)(6) 2015.

• Brand Name: TRIATHLON PKR BASEPLATE #3 LM/RL
• Type of Device: IMPLANT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4563048
• MDR Text Key: 20786107
• Report Number: 0002249697-2015-00567
• 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: Other,Study,other,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2015

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 5620-B-301
• Device Lot Number: JUXUA
• Other Device ID Number: STERILE LOT# MSHMR07A3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2013
• 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: 61 YR
• Patient Weight: 66