MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 51MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS

Model Number 6942-5-051

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374); Cancer (3262)

Event Date 04/27/2017

Event Type  Injury  

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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

Event Description

Patient had a proximal femoral uni polar replacement nine months ago and recently started to dislocate.

Manufacturer Narrative

Additional information: executive summary.An event regarding loosening involving a unitrax modular endo head 51mm was reported.The event was not confirmed.Method & results: device evaluation and results: not 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: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned and insufficient information was provided.It was reported that the patient had cancer which could have been a contributing factor to the alleged loosening however, further information is required to investigate this event further.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Patient had a proximal femoral uni polar replacement nine months ago and recently started to dislocate.Update as per sales rep: spoke to sales rep and he confirmed that the patient had cancer.The unipolar head loosened from the acetabulum.

• Brand Name: UNITRAX MODULAR ENDO HEAD 51MM
• Type of Device: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS
• 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: 6591518
• MDR Text Key: 75976833
• Report Number: 0002249697-2017-01669
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 07613327032451
• UDI-Public: (01)07613327032451(11)160104(17)210131(10)M04APW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014226
• 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: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 6942-5-051
• Device Catalogue Number: 6942-5-051
• Device Lot Number: M04APW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2016
• 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
• Patient Age: 19 YR