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

Model Number 530-08-108

Device Problems Material Erosion (1214); Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as loosening.The previous surgery and the surgery detailed in this event occurred 2 years and 8 months 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 kept at hospital and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical for review.The revised items were not returned for examination and the lot numbers were not provided.To adequately investigate this event, the lot numbers are necessary.Given the limited information, a search of djo and available zimmer biomet records for the previous surgery produced no results, therefore; the items could not be verified.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - patient's stem was loose.Osteolysis was present and cement was eroded.No infection was found.Baseplate/glenosphere was left in patient.Stem/poly/spacer was replaced.

• Brand Name: ALTIVATE REVERSE SHOULDER
• Type of Device: ALTIVATE REVERSE, HUMERAL STEM ,STANDARD 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: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12514934
• MDR Text Key: 272873087
• Report Number: 1644408-2021-01026
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912168304
• UDI-Public: (01)00888912168304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 530-08-108
• Device Catalogue Number: 530-08-108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention