MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. ENCORE HUMERAL SHOULDER STEM; ENCORE REVERSE SHOULDER HUMERAL STEM, PRIMARY, 42MM SHELL, SZ 14X108MM

Catalog Number 530-14-108

Device Problems Failure To Adhere Or Bond (1031); Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 09/26/2016

Event Type  Injury  

Event Description

Revision surgery - due to non fixation, loose stem.The surgeon removed all of the components and put in a antibiotic spacer.

Manufacturer Narrative

The reason for this revision surgery was device loosening.The previous surgery and the revision detailed in this investigation occurred 49 days 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.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 device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions and specifications in effect at the time the part was manufactured were met.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed to be non-product related.The root cause for the device loosening was not reported.There are multiple factors that may contribute to the reported "non fixation loose stem" that are outside of the control of djo surgical.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions, root cause, relating to this event could not be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: ENCORE HUMERAL SHOULDER STEM
• Type of Device: ENCORE REVERSE SHOULDER HUMERAL STEM, PRIMARY, 42MM SHELL, SZ 14X108MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 6058050
• MDR Text Key: 58414802
• Report Number: 1644408-2016-00809
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912168489
• UDI-Public: (01)00888912168489
• 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
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2022
• Device Catalogue Number: 530-14-108
• Device Lot Number: 415T1019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2016
• 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: 506-03-114,LOT 831C1286; 506-03-114,LOT 831C1316; 506-03-126,LOT 834C1273; 506-03-134,LOT 836C1115; 508-32-104,LOT 866C2142; 508-36-101,LOT 869C1909; 509-00-036,LOT 378P1035
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR