MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 36MM, HXE-PLUS

Model Number 509-01-036

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Unspecified Infection (1930)

Event Date 05/20/2022

Event Type  Injury  

Event Description

Revision surgery - patient had an infection and the delay in the case happen because screw in the baseplate were stripped.

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Manufacturer Narrative

The reason for this revision surgery was reported as an infection.The previous surgery and the surgery detailed in this event occurred 7 months and 1 week apart.The healthcare professional indicated there was 1 hour 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 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 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 possible 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, 36MM, HXE-PLUS
• 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: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 14645971
• MDR Text Key: 293690781
• Report Number: 1644408-2022-00722
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144629
• UDI-Public: (01)00888912144629
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2024
• Device Model Number: 509-01-036
• Device Catalogue Number: 509-01-036
• Device Lot Number: 382P1065
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2019
• 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
• Treatment: 506-03-118 LOT 832C1837; 506-03-126 LOT 834C1856; 506-03-126 LOT 834C1884; 508-32-204 LOT 769P2143; 508-36-101 LOT 869C3298; 530-12-108 LOT 412T1567
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male