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

Model Number	510-00-010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2020
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 - stem became loose due to a fracture.
Additional Manufacturer Narrative
Corrected data: see e.1.Manufacturer narrative: the reason for this revision surgery was reported as loosening and fracture.The previous surgery and the surgery detailed in this event occurred 6 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) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was a nonconformance associated with the main part #510-00-010, rsp, primary humeral monoblock, 10mm x 108 which documents that out of 20 parts lot, 1 part was rejected and scrapped during part verification.All other item in the lot were met with the design, fit and function requirements.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 loosening and fracture.There were no findings during this evaluation that indicate the reported devices were defective.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.Agent has clearly mentioned that "stem became loose due to a fracture" it seems that the event may possibly occurred due to lack of care, poor bone density, patient bone deterioration, inadequate soft tissue support, prolonged overhead activities, patient activities or trauma.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, 10MM X 108
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 10276651
• Report Number: 1644408-2020-00595
• Device Sequence Number: 2613463
• Product Code: PHX
• UDI-Device Identifier: 00888912024822
• UDI-Public: (01)00888912024822
• 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: 2014
• 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): 08/24/2020

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: 04/30/2020
• Device Model Number: 510-00-010
• Device Catalogue Number: 510-00-010
• Device Lot Number: 980F1113
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/24/2020
• 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: 508-00-436 LOT 919F1025; 508-32-101 LOT 862C1411; 508-00-436 LOT 919F1025; 508-32-101 LOT 862C1411
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR