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

Model Number 509-00-436

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Discomfort (2330)

Event Date 05/07/2019

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was due to discomfort.The previous surgery and the surgery detailed in this investigation occurred 5.8 months apart.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 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 component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of 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 discomfort.There were no findings during this investigation that indicate that the reported device was 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 contribute to an event that are outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - due to the patient experiencing discomfort; the surgeon performed an irrigation & drainage and poly exchange.

• Brand Name: RSP SHOULDER
• 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
• 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: 8676274
• MDR Text Key: 147251283
• Report Number: 1644408-2019-00502
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888912144582
• UDI-Public: (01)00888912144582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/06/2019

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: 09/21/2023
• Device Model Number: 509-00-436
• Device Catalogue Number: 509-00-436
• Device Lot Number: 386P1076
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR