MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP; RSP BASEPLATE, 30MM, W/P2 COATING

Model Number 508-32-204

Device Problems Positioning Problem (3009); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Unspecified Infection (1930)

Event Date 11/20/2020

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 - failed baseplate.Original position of baseplate was almost 90° to the face of the glenoid.Possible infection as well, surgeon removed old baseplate and glenosphere and replaced with 36 neutral and semi constrained poly.

Manufacturer Narrative

Corrected data: manufacturer narrative: the reason for this revision surgery was reported as broken baseplate central screw and a possible infection.The previous surgery and the surgery detailed in this event occurred 5 months and 3 weeks apart.The outcome of this event was disability and permanent damage to the patient.The healthcare professional indicated there was 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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements and showed no non-conforming material reports (ncmr) associated with the main contributor component listed in the complaint.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 a revision surgery due to a broken baseplate central screw and a possible infection.There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with the broken center screw or the patient's infection.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 inhibited the patient's immune system.There are multiple factors that may contribute to an event that are outside the control of djo surgical.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.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as broken baseplate central screw and a possible infection.The previous surgery and the surgery detailed in this event occurred 5 months and 3 weeks apart.Disability or permanent damage was reported.The healthcare professional indicated there was 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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements and showed no non-conforming material reports (ncmr) associated with the main contributor component listed in the complaint.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 a revision surgery due to a broken baseplate central screw and a possible infection.There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with the broken center screw or the patient's infection.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 broken center screw or inhibited the patient's immune system.There are multiple factors, outside the control of djo surgical, that may contribute to an event.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: RSP
• Type of Device: RSP BASEPLATE, 30MM, W/P2 COATING
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 11037260
• MDR Text Key: 222328384
• Report Number: 1644408-2020-01169
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144391
• UDI-Public: (01)00888912144391
• Combination Product (y/n): N
• PMA/PMN Number: K112069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2021

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 Model Number: 508-32-204
• Device Catalogue Number: 508-32-204
• Device Lot Number: 769P1778
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 02/23/2021; 04/15/2021
• Supplement Dates FDA Received: 03/23/2021; 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 506-03-114 LOT 831C1770; 506-03-114 LOT 831C1771; 506-03-114 LOT 831C1777; 506-03-122 LOT 833C1610; 508-32-101 LOT 862C3088; 509-02-032 LOT 951W1402; 506-03-114 LOT 831C1770; 506-03-114 LOT 831C1771; 506-03-114 LOT 831C1777; 506-03-122 LOT 833C1610; 508-32-101 LOT 862C3088; 509-02-032 LOT 951W1402
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 67 YR