MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE SHOULDER; ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ8X108MM

Model Number 530-08-108

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 10/25/2017

Event Type  Injury  

Event Description

Revision surgery - due to the patient complaining of immense pain following her initial surgery in late august.Post operative x-rays seemed to indicate that the stem was loose and not securely press-fitted into the patient's humerus.This was confirmed during the revision surgery.The revising surgeon opted to remove the stem and liner completely, and cement a new stem and implant a thicker liner.

Manufacturer Narrative

The reason for this revision surgery was due to the patient complaining of immense pain.The previous surgery and the revision detailed in this investigation occurred 1.9 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 a significant adverse event to the patient.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.Initial or prolonged hospitalization was required.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 530-08-108, altivate reverse, humeral stem standard shell, sz 08 machined, which documents a nonconformance that out of the 15 items in the lot, 11 were rejected due to product failed to meet the profile tolerance for the porous coating boundary and it was reworked with suitable operations and were accepted.The remaining 4 items were scrapped in the dimensional and visual inspection operation.All 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 pain.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.There are many factors that may contribute to the event that are outside the control of djo surgical such as: excessive range of motion, degenerative bone disease, labral tear, patient activities or trauma.The agent has mentioned that post-operative x-rays indicated the stem was loose and not securely press-fitted into the patient's humerus.It seems that the event may have occurred due to improper implant selection/surgical technique.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: ALTIVATE SHOULDER
• Type of Device: ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ8X108MM
• 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: 7038066
• MDR Text Key: 92283262
• Report Number: 1644408-2017-01026
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

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: 03/25/2023
• Device Model Number: 530-08-108
• Device Catalogue Number: 530-08-108
• Device Lot Number: 406T1096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR