MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION TOTAL SHOULDER; HEAD, HUMERAL W/FEMALE TAPER, 42X22

Model Number 503-42-022

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 07/08/2019

Event Type  Injury  

Event Description

Revision surgery: total shoulder revised to reverse due to cuff tear and patient pain.

Manufacturer Narrative

The reason for this revision surgery was reported as pain and cuff tear.The previous surgery and the revision detailed in this investigation occurred over 14 years and 6 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.Initial or prolonged hospitalization was required.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 and showed no non-conforming material reports (ncmr) associated with the main contributor component listed in the complaint.The device and its applicable concomitant parts were within their expiration dates at the time of use during the previous surgery.Customer complaint history of the reported devices 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 pain and cuff tear.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event.There are many factors that may contribute to the event that are outside the control of djo surgical such as excessive loads or torques, degenerative bone disease, repetitive overhead activity, poor bone density, patient bone deterioration, inadequate soft tissue support, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any patient activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION TOTAL SHOULDER
• Type of Device: HEAD, HUMERAL W/FEMALE TAPER, 42X22
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 8871497
• MDR Text Key: 153666330
• Report Number: 1644408-2019-00748
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888912143530
• UDI-Public: (01)00888912143530
• Combination Product (y/n): N
• PMA/PMN Number: K950651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2009
• Device Model Number: 503-42-022
• Device Catalogue Number: 503-42-022
• Device Lot Number: 954641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 500-04-142, LOT 214212; 503-00-008, LOT 216802
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR