MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE ANATOMIC, SHORT HUMERAL STEM, 12MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 520-12-000

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - due to instability.

Manufacturer Narrative

The reason for this revision surgery, the agent reported "(patient experienced instability)".The previous surgery and the surgery detailed in this event occurred 4 years and 10 months apart.This investigation is limited in scope as only partial information was provided to (b)(6) for review.The revised items was not returned for examination and the item and or lot numbers was not provided.To adequately investigate this event, the part and lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.

• Brand Name: ALTIVATE ANATOMIC, SHORT HUMERAL STEM, 12MM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 19102527
• MDR Text Key: 340107316
• Report Number: 1644408-2024-00472
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00190446176022
• UDI-Public: 00190446176022
• 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: 04/12/2024

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: 520-12-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/13/2024
• Was Device Evaluated by Manufacturer?: No
• 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: UNKNOWN; 520-50-218 LOT: UNKNOWN
• Patient Outcome(s): Other