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

Model Number	509-00-440
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was due to patient had infection.Removed all original implants.Placed antibiotic spacers for the time being.The previous surgery and the surgery detailed in this event occurred 1.2 years apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available.The revision surgery was completed as intended and without incident.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history record show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming 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 needing a review.The root cause of this complaint was a revision surgery due to an infection.There were no findings during this evaluation that indicate that the reported device was the source or had a direct connection with the patient's infection.There are multiple factors that may contribute to an infection 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 or Problem Description
Revision surgery - due to patient had infection.Removed all original implants.Placed antibiotic spacers for the time being.

• Brand Name: REVERSE SHOULDER PROSTHESIS
• Common Device Name: RSP HUMERAL SOCKET INSERT, 40MM +4MM, STANDARD HXE-PLUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• MDR Report Key: 10030779
• Report Number: 1644408-2020-00369
• Device Sequence Number: 11686651
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

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: 07/28/2019
• Device Model Number: 509-00-440
• Device Catalogue Number: 509-00-440
• Device Lot Number: 387P1005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 05/06/2020
• 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
• Patient Age: 72 YR