MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ4 - 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-T-409B

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Tibial trial insert broke while inserting to trial with the final implants.

Manufacturer Narrative

An event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed.Method & results: -device evaluation and results:the device will not be returned for evaluation.Review of photographs were reviewed by a materials sme, who concluded that the device shows numerous indentations from repeated use, and that the fracture does not appear to be along the part¿s knit line and therefore not related to lack of material fusion at the knit line.Further communication: "from the images provided, overload would be the most likely fracture mode." -medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other events for the lot referenced.Conclusions: the event was confirmed.A review of the photo provided was conducted by a materials sme, who concluded that the device shows numerous indentations from repeated use, and that the fracture does not appear to be along the part¿s knit line and therefore not related to lack of material fusion at the knit line.Further communication with material analysis engineer: "from the images provided, overload would be the most likely fracture mode." -medical records received and evaluation: no medical records or x-rays were made available for evaluation.".

Event Description

Tibial trial insert broke while inserting to trial with the final implants.

• Brand Name: TRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ4 - 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6363158
• MDR Text Key: 68752085
• Report Number: 0002249697-2017-00689
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• 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,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5530-T-409B
• Device Lot Number: KMAWM5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 81