MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TURON SHOULDER; TURON PRIMARY HUMERAL STEM, SZ 12

Model Number 520-46-020

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Failure of Implant (1924)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as failure of hemi-arthroplasty.The previous surgery and the surgery detailed in this event occurred 4 years and 5 months 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.The devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration dates at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to failure of hemi-arthroplasty.There were no findings during this evaluation that indicate the reported devices were defective.No 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 the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, excessive range of motion, prolonged overhead activities, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - patient had a cemented hemi-arthroplasty that failed and surgeon revised him to a reverse.

Manufacturer Narrative

Corrected data see d2, d4 d11, g5, h4.

• Brand Name: TURON SHOULDER
• Type of Device: TURON PRIMARY HUMERAL STEM, SZ 12
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9285995
• MDR Text Key: 166008306
• Report Number: 1644408-2019-01123
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888912145152
• UDI-Public: (01)00888912145152
• Combination Product (y/n): N
• PMA/PMN Number: K080402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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: 07/28/2020
• Device Model Number: 520-46-020
• Device Catalogue Number: 520-01-012
• Device Lot Number: 456G1123
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 520-00-000 LOT 878C1339.; 520-00-000, LOT 878C1339.; 520-01-012 LOT 456G1123.; 520-46-020, LOT 919C1009.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR