MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; 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	05/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery: due to the patient falling and fracturing.
Additional Manufacturer Narrative
(b)(4).Manufacturer narrative: the reason for this revision surgery was due to a fracture.The previous surgery and the revision detailed in this investigation occurred 9.8 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 (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports associated with the suspect medical device listed in the complaint.The device was within it's respective expiration dates 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 the fracture.The agent has notified that the patient fell causing the fracture which shows that patient activities or trauma contributed to the event.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP SHOULDER
• 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: 6644983
• Report Number: 1644408-2017-00463
• Device Sequence Number: 1082980
• Product Code: KWS
• UDI-Device Identifier: 00888912024822
• UDI-Public: (01)00888912024822
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2017

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: 05/24/2022
• Device Model Number: 510-00-010
• Device Catalogue Number: 510-00-010
• Device Lot Number: 980F1285
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 07/27/2017
• 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: 64 YR