MAUDE Adverse Event Report: ENCORE MEDICAL LP ALTIVATE REVERSE SHOULDER; AR, SMALL SOCKET INSERT, 36MM NEUTRAL EPLUS

Model Number 509-02-036

Device Problems Crack (1135); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 05/12/2021

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 - multiple traumatic falls of the patient.She was non-compliant with her rehab and had cracked and disengaged her poly liner.

Manufacturer Narrative

The reason for this revision surgery was reported as cracked and disengaged poly liner after multiple falls.The previous surgery and the surgery detailed in this event occurred 1 year and 5 months apart.Initial or prolonged hospitalization was required.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 and showed no non-conforming material reports (ncmr) associated with the main contributor component listed in the complaint.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 cracked and disengaged poly liner after multiple falls.There were no findings during this evaluation that indicate the reported devices were defective.No other 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.Agent has clearly mentioned that "multiple traumatic falls of the patient" and there are multiple factors that may contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, prolonged overhead activities, 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.

• Brand Name: ALTIVATE REVERSE SHOULDER
• Type of Device: AR, SMALL SOCKET INSERT, 36MM NEUTRAL EPLUS
• Manufacturer (Section D): ENCORE MEDICAL LP; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 11961770
• MDR Text Key: 255057726
• Report Number: 1644408-2021-00550
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00190446257592
• UDI-Public: (01)00190446257592
• Combination Product (y/n): N
• PMA/PMN Number: K172351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Model Number: 509-02-036
• Device Catalogue Number: 509-02-036
• Device Lot Number: 955W1021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 508-36-103 LOT 871C1161
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR