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

Model Number	503-42-022
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery: total shoulder revised to reverse due to cuff tear and patient pain.
Additional 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
• Common Device Name: 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
• Report Number: 1644408-2019-00748
• Device Sequence Number: 1811991
• Product Code: KWS
• UDI-Device Identifier: 00888912143530
• UDI-Public: (01)00888912143530
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K950651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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): 08/27/2019

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: 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
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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: 500-04-142, LOT 214212; 503-00-008, LOT 216802
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR