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

Catalog Number	510-00-010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to an infection causing loosening of the humeral component.
Additional Manufacturer Narrative
The reason for this revision surgery was an infection that caused loosening of the humeral component.The previous surgery and the revision detailed in this investigation occurred over 2.8 years apart.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to an infection.The healthcare professional indicated there was a life threatening, serious risk to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.Initial or prolonged hospitalization was required.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 components 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 an infection.The device was within it's respective expiration date at the time of use during the previous surgery.Customer complaint history of the 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 an infection.The root cause for the infection was not reported.There were no findings during this investigation that indicate that the reported device(s) was the source or had a direct connection with the patient's infection.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 infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.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: 6401073
• Report Number: 1644408-2017-00148
• Device Sequence Number: 19076391
• Product Code: KWS
• UDI-Device Identifier: 00888912024822
• UDI-Public: (01)00888912024822
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2017

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: 02/28/2020
• Device Catalogue Number: 510-00-010
• Device Lot Number: 980F1103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 04/19/2017
• 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 855C1281
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other; Required Intervention