MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. RSP; SOCKET, INSERT 36MM SEMI RSP HUMERAL

Model Number	508-01-036
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as an infection.The previous surgery and the revision detailed in this investigation occurred 4.3 years apart.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 or inhibited the patient's immune system.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 device history records (dhrs) showed no non-conforming material reports associated with the main contributor component listed in the complaint.The device and its applicable concomitant devices were within its respective 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 device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.The root cause of this complaint was a revision surgery due to an infection.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 infection.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 infection or inhibited the patient's immune system.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 - loosening & infection.

• Brand Name: RSP
• Common Device Name: SOCKET, INSERT 36MM SEMI RSP HUMERAL
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin texas 78758
• MDR Report Key: 8765285
• Report Number: 1644408-2019-00624
• Device Sequence Number: 19252551
• Product Code: PHX
• UDI-Device Identifier: 00888912024709
• UDI-Public: (01)00888912024709
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 07/02/2019

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: 08/28/2017
• Device Model Number: 508-01-036
• Device Catalogue Number: 508-01-036
• Device Lot Number: 860C1016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 506-00-012 LOT 817C1071; 506-03-114 LOT 831C1204; 506-03-134 LOT 836C1077; 506-03-134 LOT 836C1079; 508-00-000 LOT 848C1909; 508-32-104 LOT 866C1856; 508-36-101 LOT 869C1256
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR