MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP; RSP, PRIMARY HUMERAL MONOBLOCK, 6MM X 108

Model Number	510-00-006
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - loosening of stem due to inadequate mant as.
Event or Problem Description
Revision surgery - loosening of stem due to inadequate mantle.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as loose stem from inadequate cement mantle.The previous surgery and the surgery detailed in this event occurred 7.3 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 a revision surgery due to loose stem from inadequate cement mantle.There were no findings during this evaluation that indicate the reported devices were defective.No other 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.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: RSP
• Common Device Name: RSP, PRIMARY HUMERAL MONOBLOCK, 6MM X 108
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 11614868
• Report Number: 1644408-2021-00241
• Device Sequence Number: 14215450
• Product Code: PHX
• UDI-Device Identifier: 00888912024792
• UDI-Public: (01)00888912024792
• 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: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 02/28/2018
• Device Model Number: 510-00-006
• Device Catalogue Number: 510-00-006
• Device Lot Number: 977F1028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/12/2021
• 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: 508-00-032 LOT 855C1248; 508-32-103 LOT 864C1350; 508-00-032 LOT 855C1248; 508-32-103 LOT 864C1350
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR