MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI 8MM OFFSET ADAPTER TRIAL; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 5570-T-080A

Device Problems Break (1069); Sticking (1597); Device Inoperable (1663)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Tibial offset adapter 5570-t-080a broke off tibial baseplate trial 5570-t-500 after steps in the surgical procedure were skipped per the surgeon.After continuous pounding on the trial into an unprepared tibia, the locking mechanism on the offset adapter failed.This resulted in the tibial offset adaptor and stem becoming stuck inside the patient.A tibial tubercle osteotomy needed to be performed to remove the trials from the patient.

Manufacturer Narrative

Corrected data: device not returned.An event regarding user error involving a triathlon adapter was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: review of the device history records indicate 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 event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Moreover, as per the communication received, tibial offset adapter broke and stuck inside the patient.It's just a mistake by the surgeon who skipped the steps of surgical procedure.As per procedure, thread the offset adapter into the baseplate until the jam nut bottoms out on the tibial baseplate boss.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Tibial offset adapter 5570-t-080a broke off tibial baseplate trial 5570-t-500 after steps in the surgical procedure were skipped per the surgeon.After continuous pounding on the trial into an unprepared tibia, the locking mechanism on the offset adapter failed.This resulted in the tibial offset adaptor and stem becoming stuck inside the patient.A tibial tubercle osteotomy needed to be performed to remove the trials from the patient.

• Brand Name: TRI 8MM OFFSET ADAPTER TRIAL
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6552547
• MDR Text Key: 74677034
• Report Number: 0002249697-2017-01463
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5570-T-080A
• Device Lot Number: P5V25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2011
• 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): Required Intervention
• Patient Age: 65 YR