MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 46, E-PLUS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number 521-07-246

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

Patient Problem Joint Laxity (4526)

Event Date 10/09/2023

Event Type  Injury  

Event Description

Revision surgery - due to loosening.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2021-00696; 521-07-246, s810 - device loosening, revision surgery if additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 46, E-PLUS
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18044497
• MDR Text Key: 327016632
• Report Number: 1644408-2023-01563
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00190446178378
• UDI-Public: 00190446178378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162024
• 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: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 521-07-246
• Device Lot Number: 892U1012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2023
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 520-07-000 LOT: 888U1006; 520-50-320 LOT: 879U1002
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male