MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP STANDARD HUMERAL SOCKET INSERT, 32MM, HXE-PLUS; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 509-00-032

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2023

Event Type  malfunction  

Event Description

Instrument failure - 30 minute delay in surgery.

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

See d4 expiration date and h4 the agent reported that (implant opened incorrectly due to similarity of packing to the small shell version) this event occurred during surgery, away from the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, with a thirty-minute delay.The implant was inspected prior to use and was deemed unacceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Rma evaluation: the implant was not returned to djo for further examination, the implant has been marked as lost or discarded.If the implant were to be returned to djo surgical an amendment will be opened to gather additional information.A review of 509-00-032 device history record (dhr) revealed the implant, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of this implant.Complaint database review showed one previous complaint but there were no indications that this implant has a design or material deficiency.The root cause of this complaint is difficult to determine since the device was not returned for evaluation.According to the description though, the implant was opened incorrectly, and it is probable that the procedure was not followed on how the implant was handled.This is not an event associated with a product failure, malfunction, or issue.

• Brand Name: RSP STANDARD HUMERAL SOCKET INSERT, 32MM, HXE-PLUS
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 17866051
• MDR Text Key: 324886075
• Report Number: 1644408-2023-01428
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144537
• UDI-Public: 00888912144537
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 509-00-032
• Device Lot Number: 377P1678
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other