MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH FEMORAL IMPACTOR EXTRACTOR

Model Number 6541-4-807

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Notified by dr.He had a patient come in his clinic.After radiographs we¿re taken a foreign body was noticed on the anterior aspect of the tibia baseplate.After not being able to identify the foreign body surgery was scheduled for the following day tuesday january 5th.After exploring the knee the foreign body was located and removed.Upon close examination it was determined the foreign body was a broken piece from the triathlon femoral impact or/extractor.Product number 6541-4-807.No evidence of wear on any implanted components so the implants were not revised.

• Brand Name: FEMORAL IMPACTOR EXTRACTOR
• Type of Device: EXTRACTOR
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11259352
• MDR Text Key: 229648328
• Report Number: 0002249697-2021-00182
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07613327241068
• UDI-Public: 07613327241068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• 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
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6541-4-807
• Device Catalogue Number: 6541-4-807
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 65 YR