MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE REVERSE SHOULDER; AR, SMALL SOCKET INSERT, 32MM NEUTRAL EPLUS

Model Number 509-02-032

Device Problem Unstable (1667)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/21/2022

Event Type  Injury  

Event Description

Revision surgery - patient had instability due to an accident.Required 44 head/poly implants.

Manufacturer Narrative

The reason for this revision surgery was reported as instability.The previous surgery and the surgery detailed in this event occurred 21 days 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 a nonconformance associated with the main part #509-02-032, ar, small socket insert, 32mm neutral eplus which documents that out of 40 parts lot, 2 parts were rejected and scrapped during gather outer pack material.All other items in the lot were met with the design, fit 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 instability.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.Due to the short time between previous and revision surgery, it is also possible that the event may have been occurred due to lack of post-operative care, patient noncompliance with medical instructions, incorrect implant selection, patient activities or trauma.There are multiple factors that may also contribute to an event that are outside the control of djo surgical.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.

Manufacturer Narrative

1644408-2022-00871 was reassessed and determined to be non-reportable.

• Brand Name: ALTIVATE REVERSE SHOULDER
• Type of Device: AR, SMALL SOCKET INSERT, 32MM NEUTRAL EPLUS
• 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: 14888409
• MDR Text Key: 295144765
• Report Number: 1644408-2022-00871
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00190446257554
• UDI-Public: (01)00190446257554
• 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,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 509-02-032
• Device Catalogue Number: 509-02-032
• Device Lot Number: 951W1939
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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: 508-32-103 LOT 864C5076
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female