MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM

Model Number 508-32-104

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 07/03/2019

Event Type  Injury  

Event Description

Revision surgery - the entire baseplate came out of the glenoid.All four screws, baseplate, glenosphere were attached in one piece.Surgeon removed these implants and corrected to a hemi.

Manufacturer Narrative

The reason for this revision surgery was reported as baseplate failure.The previous surgery and the revision detailed in this investigation occurred over 1 year 9 months apart.The healthcare professional indicated there was a significant adverse event to the patient.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 components used in the previous surgery met design and manufacturing requirements and showed no non-conforming material reports (ncmr) associated with the main contributor component listed in the complaint.The device and associated parts were within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported devices 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 baseplate failure.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 event.There are many factors that may contribute to the event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, excessive range of motion, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any patient activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP
• Type of Device: BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 8853110
• MDR Text Key: 153088645
• Report Number: 1644408-2019-00711
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024754
• UDI-Public: (01)00888912024754
• 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: 08/28/2019

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: 07/20/2023
• Device Model Number: 508-32-104
• Device Catalogue Number: 508-32-104
• Device Lot Number: 866C2336
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 08/01/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 506-03-118, LOT 832C1334; 506-03-118, LOT 832C1334; 506-03-126, LOT 834C1365; 506-03-134, LOT 836C1176; 508-36-101, LOT 869C2261; 509-00-436, LOT 386P1041; 510-08-000, LOT 142G1199
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 77 YR