ALTIVATE ANATOMIC SHOULDER 521-07-242 520-46-318

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-14 for ALTIVATE ANATOMIC SHOULDER 521-07-242 520-46-318 manufactured by Encore Medical L.p..

Event Text Entries

[130458330] Revision surgery - due to dislocation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1644408-2018-01144
• MDR Report Key: 8166331
• Date Received: 2018-12-14
• Date of Report: 2019-01-28
• Date of Event: 2018-11-28
• Date Mfgr Received: 2019-01-23
• Device Manufacturer Date: 2017-07-17
• Date Added to Maude: 2018-12-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: TEFFANY HUTTO
• Manufacturer Street: 9800 METRIC BLVD
• Manufacturer City: AUSTIN TX 787585445
• Manufacturer Country: US
• Manufacturer Postal: 787585445
• Manufacturer G1: ENCORE MEDICAL L.P.
• Manufacturer Street: 9800 METRIC BLVD
• Manufacturer City: AUSTIN TX 787585445
• Manufacturer Country: US
• Manufacturer Postal Code: 787585445
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ALTIVATE ANATOMIC SHOULDER
• Generic Name: ALTIVATE ANATOMIC, OFFSET HUMERAL HEAD, 46X18
• Product Code: PAO
• Date Received: 2018-12-14
• Model Number: 521-07-242
• Catalog Number: 520-46-318
• Lot Number: 878U1010
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ENCORE MEDICAL L.P.
• Manufacturer Address: 9800 METRIC BLVD AUSTIN TX 787585445 US 787585445

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2018-12-14