MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP HUMERAL SOCKET INSERT, 40MM +4MM, STANDARD HXE-PLUS

Model Number	509-00-440
Health Effect - Clinical Code	Discharge (2225)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as drainage from surgery site.The previous surgery and the surgery detailed in this event occurred 5 days 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 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.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration dates 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 drainage from surgery site.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 many factors that may contribute to the event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.Due to the short time between previous and revision surgery, it is also possible that the event may have been occurred due to lack of post-operative care, patient noncompliance with medical instructions, improper surgical technique.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - patient continued to have drainage from surgery site for days following surgery.Surgeon decided to bring the patient back in and do a wash out with a head and liner swap.

• Brand Name: RSP
• Common Device Name: RSP HUMERAL SOCKET INSERT, 40MM +4MM, STANDARD HXE-PLUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9269880
• Report Number: 1644408-2019-01062
• Device Sequence Number: 10800777
• Product Code: PHX
• UDI-Device Identifier: 00888912144599
• UDI-Public: (01)00888912144599
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2024
• Device Model Number: 509-00-440
• Device Catalogue Number: 509-00-440
• Device Lot Number: 387P1034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 11/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention