MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. ENCORE HUMERAL SHOULDER STEM; ENCORE REVERSE SHOULDER HUMERAL STEM, PRIMARY, 42MM SHELL, SZ 6X108MM

Catalog Number	530-06-108
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/23/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Due to the patient being non compliant with the surgeons post- operation orders.Initial revision of hemi arthroplasty to a reverse was a press-fit versus cementing.
Additional Manufacturer Narrative
The reason for this revision surgery was the surgeon deemed it to be necessary to revise the patient's shoulder system; the reason the surgeon deemed is necessary was not reported.The in-vivo length of service for the patient's implant was 1.4 months.The healthcare professional indicated there was a significant adverse event to the patient.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 (b)(4) for examination.A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions and specifications in effect at the time the part was manufactured were met.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed to be non-product related.The root cause for event was reported as patient non compliance with surgeon post operation orders.The scope of this investigation is limited without having the parts available to (b)(4) for evaluation.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: ENCORE HUMERAL SHOULDER STEM
• Common Device Name: ENCORE REVERSE SHOULDER HUMERAL STEM, PRIMARY, 42MM SHELL, SZ 6X108MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 6038233
• Report Number: 1644408-2016-00799
• Device Sequence Number: 13589255
• Product Code: PHX
• UDI-Device Identifier: 00888912168243
• UDI-Public: (01)00888912168243
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2016

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: 06/21/2022
• Device Catalogue Number: 530-06-108
• Device Lot Number: 403T1022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2016
• Supplement Report FDA Received Date: 11/14/2016
• 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: Other; Required Intervention
• Patient Age: 78 YR