MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP; RSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 32MM, HXE-PLUS

Model Number 510-08-000

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 10/06/2020

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 - glenoid component loose, possible infection.

Manufacturer Narrative

The reason for this revision surgery was reported as an infection.The previous surgery and the surgery detailed in this event occurred 3.4 years apart.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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.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 an infection.There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with 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 infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection 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.

• Brand Name: RSP
• Type of Device: RSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 32MM, HXE-PLUS
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 10784316
• MDR Text Key: 214521753
• Report Number: 1644408-2020-01026
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024853
• UDI-Public: (01)00888912024853
• 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: 02/19/2021

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 Expiration Date: 03/14/2022
• Device Model Number: 510-08-000
• Device Catalogue Number: 509-01-032
• Device Lot Number: 381P1045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 506-03-114 LOT 831C1364.; 506-03-114 LOT 831C1364.; 506-03-118 LOT 832C1294.; 506-03-118 LOT 832C1294.; 506-03-122 LOT 833C1238.; 506-03-122 LOT 833C1238.; 506-03-126 LOT 834C1313.; 506-03-126 LOT 834C1313.; 508-32-101 LOT 862C2330.; 508-32-101 LOT 862C2330.; 508-32-204 LOT 769P1228.; 508-32-204 LOT 769P1228.; 509-01-032 LOT 381P1045.; 510-08-000 LOT 142G1182.; 506-03-114 LOT 831C1364; 506-03-118 LOT 832C1294; 506-03-122 LOT 833C1238; 506-03-126 LOT 834C1313; 508-32-101 LOT 862C2330; 508-32-204 LOT 769P1228; 509-01-032 LOT 381P1045
• Patient Outcome(s): Required Intervention