MAUDE Adverse Event Report: ENCORE MEDICAL L.P. SOCKET, SHELL +4MM RSP HUMERAL; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 508-00-004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Laxity (4526); Implant Pain (4561)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - due to pain and loosening.

Manufacturer Narrative

See h11.The reason for this revision surgery, doctor followed up with patient due to pain and discomfort.The dr.Sent the patient to have an x-ray and the surgeon witnessed that the humeral cup had initially rotated, loosening.However, later on the cup completely loosened.The dr.Completed revision surgery without any complications, although it was necessary to change the entire humeral component (stem, cup and insert).Note: the lot number is what was reported but we are unable to find the information in the system at the time.This investigation is limited in scope as only partial information was provided to djo surgical - austin for review.The revised item(s) was not returned for examination and the item and or lot number(s) was not provided.To adequately investigate this event, the part and lot number(s) are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported item(s) showed no present trends or on-going issues that are needing a review.To date, this is the first complaint against item 508-00-004 for loosening or rotating.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon completed revision surgery without any complications, although it was necessary to change the entire humeral construct.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.

• Brand Name: SOCKET, SHELL +4MM RSP HUMERAL
• 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: 19029790
• MDR Text Key: 339205878
• Report Number: 1644408-2024-00375
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024624
• UDI-Public: 00888912024624
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K041066
• 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: 07/15/2024

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 Catalogue Number: 508-00-004
• Device Lot Number: 852C1942
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 06/17/2024
• Supplement Dates FDA Received: 07/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male