MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TURON SHOULDER; HEAD, HUMERAL, OFFSET, 50-22

Model Number 520-50-122

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 07/14/2017

Event Type  Injury  

Event Description

Revision surgery - due to the patient presenting to the surgeon with pain and loss of motion in the right shoulder.Upon inspection and x-rays, the surgeon determined the patient had a cuff tear and recommended a reverse total shoulder to reduce pain and regain range of motion.The surgeon performed the surgery using his standard delto-pectoral incision to gain access to the joint.Once the implants were exposed he removed the head (520-50-122) and humeral neck (520-00-000), then assessed the humeral stem and removed the polyethylene glenoid (520-01-250).He then proceed to implant a glenoid baseplate and four screws.He then trialed 3 heads and the turon-to-rsp conversion shell to determine the final implants.Once comfortable with stability and range-of-motion the surgeon implanted the glenoid head, turon-to-rsp conversion shell and the polyethylene and closed.

Manufacturer Narrative

The reason for this revision surgery was due to the pain and loss of motion in the right shoulder.The previous surgery and the revision detailed in this investigation occurred over 4 years and 8 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 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 520-50-122, turon humeral head, offset which documents that out of 15 quantity lot, 1 item was scrapped due to scratches on counter bore surfaces and laser mark.Remaining 14 items were accepted.The device and its applicable concomitant devices were within their respective expiration dates 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 pain and loss of motion in the right shoulder.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.There are multiple factors that may contribute to the event that are outside the control of djo surgical are soft tissue impingement, degenerative bone, patient activities or trauma.The surgeon determined the patient had a cuff tear, so the event may possibly occurred due to repetitive overhead activity or heavy lifting over a prolonged period of time.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event 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
• Type of Device: HEAD, HUMERAL, OFFSET, 50-22
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445
• MDR Report Key: 6790814
• MDR Text Key: 82560450
• Report Number: 1644408-2017-00673
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888912025065
• UDI-Public: (01)00888912025065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 520-50-122
• Device Catalogue Number: 520-50-122
• Device Lot Number: 936C1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/12/2017
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 75