MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. ALTIVATE SHOULDER; ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ10X175MM

Model Number	530-10-175
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the stem being loose.The surgeon re-did it and cemented it.

• Brand Name: ALTIVATE SHOULDER
• Common Device Name: ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ10X175MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758 6313
• MDR Report Key: 8527144
• Report Number: 1644408-2019-00310
• Device Sequence Number: 1871241
• Product Code: PHX
• UDI-Device Identifier: 00888912168373
• UDI-Public: (01)00888912168373
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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 Model Number: 530-10-175
• Device Catalogue Number: 530-10-175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/18/2019
• 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: 509-01-436, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR