MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE ANATOMIC SHOULDER; ALTIVATE ANATOMIC CS, HUMERAL STEM AND HUMERAL NECK, SIZE 2

Model Number 520-08-021

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 12/22/2021

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as a failed rotor cuff.The previous surgery and the surgery detailed in this event occurred 1 year and 1 month apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was an ncmr# (b)(4) associated with the main part #520-08-021, altivate anatomic cs, humeral stem and neck kit, size 2 which document that out of (b)(4) parts lot 1 item was rejected and scrapped due to scratches on it.Later, the rejected were reworked and accepted after proper justification.All other items in the lot were met with fit, form and function requirements.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to cuff failure.There were no findings during this evaluation that indicate the reported devices were defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as inadequate soft tissue support, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - due to failed rotator cuff.

• Brand Name: ALTIVATE ANATOMIC SHOULDER
• Type of Device: ALTIVATE ANATOMIC CS, HUMERAL STEM AND HUMERAL NECK, SIZE 2
• 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: kiersten soderman ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 13284442
• MDR Text Key: 283999489
• Report Number: 1644408-2022-00042
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 00190446648314
• UDI-Public: (01)00190446648314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193226
• 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: 01/17/2022

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 Model Number: 520-08-021
• Device Catalogue Number: 520-08-021
• Device Lot Number: 1924A1041
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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: 520-46-216 LOT 948U1101; 521-07-246 LOT 892U1164
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male