MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP, PRIMARY HUMERAL MONOBLOCK, 10MM X 108

Model Number	510-00-010
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - patient had pain and function problems.Surgery required due to stem loosening and fractures observed via x-ray.Glenoid appears fine.After assessment by surgeon osteolysis and fractures as a result, possible infection too.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
Corrected data: see a.2., b.2., d.9.& h.3.Manufacturer narrative: the reason for this revision surgery was reported as osteolysis, fractures and possible infection.The previous surgery and the surgery detailed in this event occurred 4.1 years apart.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were not released by 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 a revision surgery due to osteolysis, fractures and possible infection.There were no findings during this evaluation that indicate the reported device was the source of the osteolysis and fractures 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 caused the osteolysis, fracture or contributed to the possible infection or inhibited the patient's immune system.There are multiple factors that may also 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.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: RSP
• Common Device Name: RSP, PRIMARY HUMERAL MONOBLOCK, 10MM X 108
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 14085942
• Report Number: 1644408-2022-00473
• Device Sequence Number: 11299587
• Product Code: PHX
• UDI-Device Identifier: 00888912024822
• UDI-Public: (01)00888912024822
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 09/27/2023
• Device Model Number: 510-00-010
• Device Catalogue Number: 510-00-010
• Device Lot Number: 980F1368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 508-00-432 LOT 918F1961
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 69 KG