MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE SHOULDER; ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ6X108MM

Model Number 509-01-432

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/08/2017

Event Type  Injury  

Event Description

Revision surgery - due to cement failure.The stem and poly were removed.

Manufacturer Narrative

The reason for this revision surgery was due to cement failure.The in-vivo length of patient service for the implant was 4 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 implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.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.This event is deemed to be non-product related.The root cause of this complaint was a revision surgery due to the cement failure.There are multiple factors that may contribute to the event that are outside the control of djo surgical are excessive loads or torques, poor penetration of cement in to the bone, improper surgical procedure, poor bone quality, patient activities or trauma.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.

Manufacturer Narrative

Corrected data: the reason for this revision surgery was due to cement failure.The in-vivo length of patient service for the implant was 4 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 implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There was a non-conforming material report (ncmr) # (b)(4) associated with the part 530-06-108, reverse shoulder humeral stem, size 6mm standard which documents a nonconformance that out of 15 quantity lot 2 items were rejected as the coating bulge was not within boundary lines on overlay.It was reworked with suitable operations 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.This event is deemed to be non-product related.The root cause of this complaint was a revision surgery due to the cement failure.There are multiple factors that may contribute to the event that are outside the control of djo surgical are excessive loads or torques, poor penetration of cement in to the bone, improper surgical procedure, poor bone quality, patient activities or trauma.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: ALTIVATE SHOULDER
• Type of Device: ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ6X108MM
• 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: 7074739
• MDR Text Key: 93456767
• Report Number: 1644408-2017-01056
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144650
• UDI-Public: (01)00888912144650
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141990
• 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,Followup
• Report Date: 01/03/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: 509-01-432
• Device Catalogue Number: 530-06-108
• Device Lot Number: 403T1010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 12/08/2017; 01/03/2018
• Supplement Dates FDA Received: 12/19/2017; 01/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2015
• 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
• Treatment: 530-06-108, LOT 403T1010
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR