MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DEDICACE. V40(TM) FEMORAL STEM; HIP IMPLANT

Catalog Number 4900-0-508

Device Problem Break (1069)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 03/01/2019

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.Device not available.

Event Description

The following event was reported: "a material vigilance incident from the operating room concerning a femoral stem - catalog#.49000508 - lot number g3113842.The medical device in question is available.The fracture of the stem was a predictable event, (thin stem and overweight patient) the patient returned to the emergency department complaining of thigh pain, immediate management".

• Brand Name: DEDICACE. V40(TM) FEMORAL STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8466444
• MDR Text Key: 140436132
• Report Number: 0002249697-2019-01475
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4900-0-508
• Device Lot Number: G3113842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention