MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP HUMERAL SOCKET INSERT, 36MM +4MM, STANDARD HXE-PLUS

Model Number 509-00-436

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 03/01/2021

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 - surgeon had a patient that was experiencing discomfort and minor pain.He decided to replace a liner, stem, and glenosphere in order to achieve a better patient outcome.

Manufacturer Narrative

The reason for this revision surgery was reported as discomfort and minor pain.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.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.This investigation is limited in scope as only partial information was provided to djo surgical for review.The revised item was not returned for examination and lot numbers were not provided.To adequately investigate this event, lot number are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.The root cause of this complaint was reported as discomfort and minor pain.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 performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.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 HUMERAL SOCKET INSERT, 36MM +4MM, STANDARD HXE-PLUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 11590547
• MDR Text Key: 242993710
• Report Number: 1644408-2021-00251
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144582
• UDI-Public: (01)00888912144582
• Combination Product (y/n): N
• PMA/PMN Number: K100741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

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: 509-00-436
• Device Catalogue Number: 509-00-436
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 508-36-101 LOT UNKNOWN; 530-10-048 LOT UNKNOWN; 508-36-101 LOT UNKNOWN; 530-10-048 LOT UNKNOWN
• Patient Outcome(s): Required Intervention