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

Model Number	503-50-022
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Revision surgery - due to a loose glenoid.The surgeon needed to convert to a reverse.
Additional 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
• Common Device Name: 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
• Report Number: 1644408-2019-00563
• Device Sequence Number: 2299103
• Product Code: KWS
• UDI-Device Identifier: 00888912143608
• UDI-Public: (01)00888912143608
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K960906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR