MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 8X108MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 530-08-108

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthralgia (2355); Joint Laxity (4526)

Event Date 10/12/2023

Event Type  Injury  

Event Description

Revision surgery - mdr - pain/loosening.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2021-00949; 530-06-048, s810 - device loosening, s807 - pain, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 8X108MM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 18088699
• MDR Text Key: 327586565
• Report Number: 1644408-2023-01575
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888912168304
• UDI-Public: 00888912168304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 530-08-108
• Device Lot Number: 406T1333
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 508-40-101 , LOT 875C1088; 509-00-440 , LOT 387P1039
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female