MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. TURON SHOULDER; TURON PEGGED GLENOID IMPLANT, SIZE 50

Catalog Number	520-01-250
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient tearing their rotator cuff, causing the turon implants to fail.
Additional Manufacturer Narrative
The reason for this revision surgery was the turon implants failed.The previous surgery and the revision detailed in this investigation occurred over 8 months apart.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to a failure.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 (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions and specifications in effect at the time the part was manufactured were met.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to a failure.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.The root cause of this complaint was a revision surgery due to turon shoulder failure.There are multiple factors that may contribute to turon implant failure that are outside the control of djo surgical are excessive load or torque, poor bone quality, inadequate soft tissue support, trauma or patient bone density.The agent has mentioned that patient tore the rotator cuff causing the turon shoulder to fail which shows that patient activities may be a reason for failure.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to a failure and hence a definitive root cause cannot be determined.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: TURON SHOULDER
• Common Device Name: TURON PEGGED GLENOID IMPLANT, SIZE 50
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 6301259
• Report Number: 1644408-2017-00044
• Device Sequence Number: 13674574
• Product Code: KWS
• UDI-Device Identifier: 00888912024976
• UDI-Public: (01)00888912024976
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2021
• Device Catalogue Number: 520-01-250
• Device Lot Number: 193G1110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 520-00-000,LOT 878C1582; 520-01-014,LOT 457G1112; 520-50-122,LOT 936C1079
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR