MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP HUM SOCKET INSERT, 36MM +4MM, STANDARD

Model Number	508-00-436
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to these documents as soon as it becomes available.
Event or Problem Description
Revision surgery - patient presented to surgeon with pain in the left shoulder.Upon further tests and work-ups, it was probability the patient's left shoulder was infected.Then surgeon extracted the above notated implants in a surgical procedure at the university of colorado hospital.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as possible infection.The previous surgery and the surgery detailed in this event occurred 2.8 years 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 date 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 reported as a possible infection.There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with the patient's possible 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 possible infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP
• Common Device Name: RSP HUM SOCKET INSERT, 36MM +4MM, STANDARD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9860733
• Report Number: 1644408-2020-00244
• Device Sequence Number: 17002189
• Product Code: PHX
• UDI-Device Identifier: 00888912024686
• UDI-Public: (01)00888912024686
• 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: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 03/23/2022
• Device Model Number: 508-00-436
• Device Catalogue Number: 508-00-436
• Device Lot Number: 919F1910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/17/2020
• 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: 506-03-118 LOT 832C1318; 506-03-118 LOT 832C1324; 506-03-126 LOT 834C1332; 506-03-130 LOT 835C1329; 508-32-104 LOT 866C2295; 508-36-101 LOT 869C2199; 530-10-108 LOT 409T1165
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR