MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ6 - 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-T-609B

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 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Surgeon broke two trial inserts while doing the final trailing.

Manufacturer Narrative

An event regarding crack/fracture involving a triathlon insert trial was reported.The event was confirmed.Method and results: -device evaluation and results: a material analysis has been performed.The report concluded: "both inserts broke in overload.Notable surface damage was found on both inserts indicating that the trials had been impacted during use.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: not performed as there is no indication the reported event was related to patient factors.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the event was confirmed.A material analysis has been performed.The report concluded: "both inserts broke in overload.Notable surface damage was found on both inserts indicating that the trials had been impacted during use.No material or manufacturing defects were observed on the surfaces examined.".

Event Description

Surgeon broke two trial inserts while doing the final trailing.

• Brand Name: TRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ6 - 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: suzanne neuschwanter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6298026
• MDR Text Key: 66664749
• Report Number: 0002249697-2017-00435
• 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: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5530-T-609B
• Device Lot Number: KMASR2E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2016
• 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: 68 YR
• Patient Weight: 86