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

Model Number 509-01-032

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Inadequate User Interface (2958)

Patient Problem Failure of Implant (1924)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was due to dislocation.The previous surgery and the revision detailed in this investigation occurred over 12 days apart.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported components used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports associated with the product that may have contributed to the event.The device was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to dislocation.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event.The agent has clearly mentioned that the patient was noncompliant with post-operative care and instructions which resulted in a dislocated shoulder.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any patient activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - due to the patient being noncompliant.Patient does not follow post operation instruction, complete physical therapy or go to follow up appointments.Patient present two weeks post operation with dislocated 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: teffany hutto ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 8851764
• MDR Text Key: 152969260
• Report Number: 1644408-2019-00720
• 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: 08/01/2019

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: 01/16/2024
• Device Model Number: 509-01-032
• Device Catalogue Number: 509-01-032
• Device Lot Number: 381P1096
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2019
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR