MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; STEM, HUMERAL SIZE8 RSP

Model Number	506-00-008
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as humeral fracture and loose stem.The previous surgery and the surgery detailed in this event occurred 10 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.The item lot numbers were not provided, therefore, the items could not be linked to a specific device history record or the date of manufacture cannot be determined with confidence.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 humeral fracture and loose stem.The findings did not lead to a firm conclusion since the item lot numbers were not available at the time of this investigation.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 multiple factors that may contribute to an event that are outside 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 - humeral fracture at distal tip of stem.Humeral stem loosening.

• Brand Name: RSP
• Common Device Name: STEM, HUMERAL SIZE8 RSP
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• MDR Report Key: 9938657
• Report Number: 1644408-2020-00273
• Device Sequence Number: 2078199
• Product Code: PHX
• UDI-Device Identifier: 00888912024389
• UDI-Public: (01)00888912024389
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 04/06/2020

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 Model Number: 506-00-008
• Device Catalogue Number: 506-00-008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/08/2020
• 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