MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE SHOULDER; ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ10X108MM

Model Number 530-10-108

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 11/10/2017

Event Type  Injury  

Event Description

Second revision surgery - due to the patient being non-compliant with post operation care.She kept dislocating shoulder.

Manufacturer Narrative

The reason for this revision surgery is due to a dislocation.The previous surgery and the revision detailed in this investigation occurred 2.8 months apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There was a non-conforming material report (ncmr) # (b)(4) associated with the part 530-10-108, altivate reverse, humeral stem, size 10mm standard which documents a nonconformance that out 15 quantity lot 1 item was scraped due to blasting in porous coating.All remaining items in the lot met the fit, design and functional requirements.The device was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to the dislocation.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's dislocation.There are multiple factors that may contribute to the event that are outside the control of djo surgical such as: patient activities, inadequate soft tissue support, excessive range of motion, patient bone deterioration or trauma.Agent has clearly mentioned that the patient was non-compliant with post-operative care and kept dislocating, it implies that the event had occurred due to the patient being non-compliant with post-operative instructions.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

Manufacturer Narrative

D10 - adding concomitant part 402283.

• Brand Name: ALTIVATE SHOULDER
• Type of Device: ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ10X108MM
• 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: 7100491
• MDR Text Key: 94263682
• Report Number: 1644408-2017-01126
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912168366
• UDI-Public: (01)00888912168366
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2023
• Device Model Number: 530-10-108
• Device Catalogue Number: 530-10-108
• Device Lot Number: 409T1196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 01/11/2018; 01/11/2018
• Supplement Dates FDA Received: 01/15/2018; 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2017
• 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: 402283 COBALT G-HV BONE CEMENT 40G; 508-32-101, LOT 852C2371; 509-01-432, LOT 389P1045; 510-08-000, LOT 142G1109; 508-32-101, LOT 852C2371; 509-01-432, LOT 389P1045; 510-08-000, LOT 142G1109
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female