MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. TURON SHOULDER; TURON PEGGED GLENOID IMPLANT, SIZE 42

Model Number	520-46-016
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient having a rotator cuff tear and having to be converted to a reverse shoulder.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was the patient had a rotator cuff tear and had to be converted to a reverse shoulder.The in-vivo length of patient service for the implant was 5.8 months.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed to be non-product related.The root cause for the rotator cuff tear was not reported.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions relating to this event could not be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
Additional Manufacturer Narrative
D10: adding concomitant part 402283.

• Brand Name: TURON SHOULDER
• Common Device Name: TURON PEGGED GLENOID IMPLANT, SIZE 42
• 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: 6227285
• Report Number: 1644408-2016-01023
• Device Sequence Number: 19067148
• Product Code: KWS
• UDI-Device Identifier: 00888912145145
• UDI-Public: (01)00888912145145
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2022

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: 01/31/2020
• Device Model Number: 520-46-016
• Device Catalogue Number: 520-01-242
• Device Lot Number: 191G1094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided; 01/25/2017
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 02/14/2017; 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 402283 COBALT G-HV BONE CEMENT 40G; 520-00-000, LOT 878C1593; 520-01-008, LOT 454G1085; 520-01-242, LOT 191G1094; 520-00-000, LOT 878C1593; 520-01-008, LOT 454G1085; 520-01-242, LOT 191G1094
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female