MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP; RSP, PRIMARY HUMERAL MONOBLOCK, 8MM X 108

Model Number	510-00-008
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - periprosthetic fracture.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as peri-prosthetic fracture.The previous surgery and the revision detailed in this investigation occurred over 3 years and 5 months 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 device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.The device and its applicable concomitant devices were within their 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 root cause of this complaint was a revision surgery due to peri-prosthetic fracture.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 event.There are multiple factors that may contribute to the event that are outside the control of djo surgical such as prolonged overhead activities, poor bone density, patient bone deterioration, patient activities, or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP
• Common Device Name: RSP, PRIMARY HUMERAL MONOBLOCK, 8MM X 108
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd.; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 8803838
• Report Number: 1644408-2019-00657
• Device Sequence Number: 320122
• Product Code: PHX
• UDI-Device Identifier: 00888912024815
• UDI-Public: (01)00888912024815
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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: 12/23/2021
• Device Model Number: 510-00-008
• Device Catalogue Number: 510-00-008
• Device Lot Number: 979F1227
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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: 508-00-436 LOT 919F1902; 508-36-101 LOT 869C2001; 508-00-436 LOT 919F1902; 508-36-101 LOT 869C2001
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR