MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TURON SHOULDER; TURON PRIMARY HUMERAL STEM, SZ 8

Model Number	520-01-008
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient having a rotator cuff tear.The surgeon removed all original implants and converted to a reverse shoulder.
Additional Manufacturer Narrative
The reason for this revision surgery was due to the rotator cuff failure.The previous surgery and the revision detailed in this investigation occurred 1 year and 8 months apart.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 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, 520-01-008, turon primary humeral stem, size 8 which documents a nonconformance that out of (b)(4) quantity lot, (b)(4) items were rejected due to multiple scuffs on polished distal stem.Rejected items were reworked with suitable operations.All items in the lot met the design, fit and function requirements and were accepted.The device was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device 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 the rotator cuff failure.There are multiple factors that may contribute to the event that are outside the control of djo surgical such as: repetitive shoulder motions, excessive load or torque, degenerative bone, poor bone density, excessive overhead work, patient activities or trauma.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 PRIMARY HUMERAL STEM, SZ 8
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7281191
• Report Number: 1644408-2018-00139
• Device Sequence Number: 16183960
• Product Code: KWS
• UDI-Device Identifier: 00888912144902
• UDI-Public: (01)00888912144902
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: 01/29/2022
• Device Model Number: 520-01-008
• Device Catalogue Number: 520-01-008
• Device Lot Number: 454G1098
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 02/27/2018
• 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 878C1589; 520-46-116, LOT 923C1075; 521-01-242, LOT 799N1006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR