MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #4 CR INSERT 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530P409

Device Problems Difficult to Insert (1316); Mechanical Problem (1384); Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested but not provided due to hospital policy.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It is reported by a nurse of the hospital that the snap ring was deformed and inserting wasn't possible.Replacement was available.

Manufacturer Narrative

An event regarding a seating/locking issue involving a triathlon insert was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection of the returned component indicates that the types of damage observed on the insert are indicative of an attempt to assemble the insert with a baseplate component.-medical records received and evaluation: not performed as no medical records were provided.-device history review: indicated devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review of the reported lot confirms no other similar events reported.Conclusions: based on the visual inspection of the returned component, it appears that an attempt was made to assemble the insert with a baseplate component.No further investigation for this event is required at this time.

Event Description

It is reported by a nurse of the hospital that the snap ring was deformed and inserting wasn't possible.Replacement was available.

• Brand Name: TRIATHLON #4 CR INSERT 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick 00000
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5145535
• MDR Text Key: 28486443
• Report Number: 0002249697-2015-03330
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 5530P409
• Device Lot Number: LEJ035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2015
• 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