MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TURON SHOULDER; TURON PEGGED GLENOID IMPLANT, SIZE 38

Catalog Number	520-01-238
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	01/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery: due to a failed total shoulder that the surgeon converted to a reverse.
Additional Manufacturer Narrative
The reason for this revision surgery was a failed total shoulder.The previous surgery and the revision detailed in this investigation occurred 5 years 11 months 17 days apart.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.Initial or prolonged hospitalization was required.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported components used in the previous surgery met design and manufacturing requirements.There was a non-conforming material report (ncmr) (b)(4) associated with the part 520-01-238, turon glenoid pegged which documents a non-conformance that out of 15 component lot, 1 item with engraving legibility moved to scrap and the remaining items were accepted.The device and its applicable concomitant devices were verified to have gone through acceptable sterilization processes and were within their respective expiration date at the time of use during the previous surgery.The customer complaint history of the reported device (s) showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to a failed total shoulder.There are multiple factors which may cause shoulder failure that are outside the control of djo surgical are patient weight, patient activities, excessive range-of-motion, trauma or patient bone quality.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 shoulder 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.The revision surgery was completed successfully.

• Brand Name: TURON SHOULDER
• Common Device Name: TURON PEGGED GLENOID IMPLANT, SIZE 38
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6291694
• Report Number: 1644408-2017-00037
• Device Sequence Number: 13847320
• Product Code: KWS
• UDI-Device Identifier: 00888912024945
• UDI-Public: (01)00888912024945
• 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: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

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: 10/31/2015
• Device Catalogue Number: 520-01-238
• Device Lot Number: 190G1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 03/29/2017
• 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 A1000014; 520-01-008, LOT 454G1004; 520-42-120, LOT 53984071
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR