MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE REVERSE SHOULDER; ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 6X108MM

Model Number 509-02-432

Device Problems Failure to Align (2522); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - patient had a failure of the cement mantle, causing a valgus alignment of the humeral stem.Patient was experiencing pain and surgeon decided to revise the components.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as cement mantle failure causing pain.The previous surgery and the surgery detailed in this event occurred 1.3 years 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 record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) associated with the products that may have contributed to the reported event.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 cement mantle failure causing pain.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 contribute to the 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.

Manufacturer Narrative

D10: adding concomitant part 600-15-100.

• Brand Name: ALTIVATE REVERSE SHOULDER
• Type of Device: ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 6X108MM
• 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: teffany hutto ; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 10343451
• MDR Text Key: 201358641
• Report Number: 1644408-2020-00650
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00190446257578
• UDI-Public: (01)00190446257578
• 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,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 509-02-432
• Device Catalogue Number: 533-06-108
• Device Lot Number: 923W1041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2018
• 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 864C2541; 508-32-103 LOT 864C2541; 509-02-432 LOT 953W1056; 533-06-108 LOT 923W1041; 600-15-100 COBALT G-HV BONE CEMENT 40GM
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 93 KG