MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. TURON SHOULDER; NECK, HUMERAL, NEUTRAL

Catalog Number 520-00-000

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 07/07/2015

Event Type  Injury  

Event Description

Revision surgery - due to subscapular failure.

Manufacturer Narrative

The reason for this revision surgery was a sub scap failure.The length of in vivo service is a 10.6 months.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records showed no non-conforming material reports associated with the component listed in the complaint.A review of the product complaint report history showed there have been 42 prior complaints reported against this part number; summary of investigations: 1 for incorrect features, 1 for revision surgery, 3 for dislocation, 1 for wear/excessive wear, 4 for pain, 3 for infection, 10 for trauma, 18 for stability/poor joint, and 1 for dissociation.This is the first complaint against this lot number.The root cause of this event was not reported.The surgeon reported no issues associated with the product.No other conditions relating to this event could be determined with confidence.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: TURON SHOULDER
• Type of Device: NECK, HUMERAL, NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 4910149
• MDR Text Key: 6051948
• Report Number: 1644408-2015-00417
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2015

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 Expiration Date: 05/31/2020
• Device Catalogue Number: 520-00-000
• Device Lot Number: 878C1370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 07/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2014
• 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
• Treatment: 520-46-020,LOT 919C1032; 520-01-246,LOT 192G1080
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR