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

Model Number 509-01-032

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 12/03/2021

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as dislocation.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could not 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.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 dislocation.There were no findings during this evaluation that indicate the reported devices were defective.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 event.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.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.

Event Description

Revision surgery - patient presented in surgeon office with a painful shoulder.Upon x-ray review it was determined that the patient had a dislocated shoulder.Surgery was scheduled to revise the shoulder.

• 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
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 13095887
• MDR Text Key: 282887705
• Report Number: 1644408-2021-01493
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144612
• UDI-Public: (01)00888912144612
• 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
• Report Date: 12/28/2021

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: 02/07/2023
• Device Model Number: 509-01-032
• Device Catalogue Number: 509-01-032
• Device Lot Number: 381P1072
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2018
• 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: 510-08-000 LOT 142G1355
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male