MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION SHOULDER; GLENOID, UNIFORM, PEGGED 50MM CM FOUNDATION SHOULDER

Model Number 503-50-022

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was due to loosening.The previous surgery and the revision detailed in this investigation occurred over 10 years and 9 months 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.There are no reported pre-existing patient health conditions.Initial or prolonged hospitalization was required.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.The root cause of this complaint was a revision surgery due to loosening.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: loose joints from inadequate soft tissue support, degenerative bone, patient bone deterioration, patient activities or trauma.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - due to a loose glenoid.The surgeon needed to convert to a reverse.

Manufacturer Narrative

Corrected data: see brand name, common device name, concomitant medical products, and device manufacture date.Manufacturer narrative: the reason for this revision surgery was reported as loosening.The previous surgery and the revision detailed in this investigation occurred over 10 years and 9 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.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the event.The device and its applicable concomitant device was within its respective expiration date 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 loosening.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 are loose joints from inadequate soft tissue support, degenerative bone, patient bone deterioration, 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.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION SHOULDER
• Type of Device: GLENOID, UNIFORM, PEGGED 50MM CM FOUNDATION SHOULDER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445 TX 78758 6313
• MDR Report Key: 8653725
• MDR Text Key: 146488669
• Report Number: 1644408-2019-00563
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888912143608
• UDI-Public: (01)00888912143608
• Combination Product (y/n): N
• PMA/PMN Number: K960906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Model Number: 503-50-022
• Device Catalogue Number: 500-04-150
• Device Lot Number: 53926394
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 500-04-150, LOT 53926394; 503-00-008 LOT 53926935; 503-00-008, LOT 53926935; 503-50-022 LOT 53916882; 500-04-150, LOT 53926394; 503-00-008, LOT 53926935
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR