MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; SOCKET, INSERT 36MM STD. RSP HUMERAL

Model Number 508-00-036

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 05/06/2018

Event Type  Injury  

Event Description

Revision surgery - a reverse for fracture was done on original surgery date and at this time a repair of tuberosities was done on the patient.At the time of surgery, a 36 standard humeral socket insert was used and appropriate.Upon the post-operative x-ray examination, it was noted that the tuberosities had failed.Due to this occurrence, it was decided by the surgeon to bring the patient back for re-evaluation in the operating room.At that time it was decided to replace the 36 standard insert with a 36 +4 insert.All original screws from the 1st surgery stayed in the patient.The 3.5 screw was used to disengage the 34 standard poly.

Manufacturer Narrative

The reason for this revision surgery was due to tuberosities failure.The previous surgery and the revision detailed in this investigation occurred 1 day 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 were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.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 tuberosities failure.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 inadequate soft tissue support, degenerative bone, patient bone deterioration or aging of the patient.The revision surgery occurred on a day after previous surgery.It seems that the event may have possibly occurred due to improper implant selection or 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: RSP SHOULDER
• Type of Device: SOCKET, INSERT 36MM STD. RSP HUMERAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7544866
• MDR Text Key: 109269718
• Report Number: 1644408-2018-00475
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024655
• UDI-Public: (01)00888912024655
• Combination Product (y/n): N
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

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: 02/16/2023
• Device Model Number: 508-00-036
• Device Catalogue Number: 508-00-036
• Device Lot Number: 856C1959
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR