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

Model Number 533-06-108

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 11/02/2020

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 was experiencing shoulder pain and discomfort so the surgeon did a revision surgery.

Manufacturer Narrative

The reason for this revision surgery was reported as pain and discomfort.The previous surgery and the surgery detailed in this event occurred 5 months 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 kept at the 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 were no non-conforming material reports (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 reported as a revision surgery due to pain and discomfort.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 an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, 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: ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 6X108MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 10920126
• MDR Text Key: 218703172
• Report Number: 1644408-2020-01123
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00190446259091
• UDI-Public: (01)00190446259091
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 533-06-108
• Device Catalogue Number: 533-06-108
• Device Lot Number: 923W1149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 509-02-032 LOT 951W1377; 509-02-032 LOT 951W1377
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR