MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE REVERSE SHOULDER; ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X108MM

Model Number 533-08-108

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2022

Event Type  Injury  

Event Description

Revision surgery: the patient had a loose humeral stem and the surgeon removed the current stem and replaced with a new one with a cement plug and cement.

Manufacturer Narrative

The reason for this revision surgery was reported as loosening.The previous surgery and the surgery detailed in this event occurred 1 month and 3 weeks 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 #533-08-108, altivate reverse, humeral stem, small shell, sz8x108mm which document that out of 15 parts lot all the parts were rejected due to uneven polish in flute regions, and grain growth in polished area.Later, the rejected parts were reworked and accepted after proper justification.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 loosening.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 poor bone density, inadequate soft tissue support, patient activities.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.

• Brand Name: ALTIVATE REVERSE SHOULDER
• Type of Device: ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X108MM
• 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: 13956055
• MDR Text Key: 288271026
• Report Number: 1644408-2022-00393
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00190446259121
• UDI-Public: (01)00190446259121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172351
• 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: 03/30/2022

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: 533-08-108
• Device Catalogue Number: 533-08-108
• Device Lot Number: 926W1564
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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: 509-02-040 LOT 959W1049
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female