MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 2. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5537-G-216

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device and medical records were not made available to the manufacturer due to hospital and surgeon policy.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.Device not returned to the manufacturer.

Event Description

Right knee revision - due to traumatic patella tendon rupture and knee dislocation.

Manufacturer Narrative

An event regarding dislocation involving a triathlon ts insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned for inspection.Medical records received and evaluation: not performed as no medical records were provided for review.Device history review: review of the device history records indicate all devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: there have been no other events for the lot referenced.Conclusions: the exact cause of the event could not be determined because the device was not returned for investigation and no patient medical records were provided for review.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

Right knee revision - due to traumatic patella tendon rupture and knee dislocation.

• Brand Name: NO 2. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5114761
• MDR Text Key: 27173561
• Report Number: 0002249697-2015-03188
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 5537-G-216
• Device Lot Number: MLEKP4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2012
• 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: 69 YR
• Patient Weight: 108