MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE REVERSE SHOULDER; ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ6X175MM

Model Number	530-06-175
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery.Patient fell and bent the stem.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as bent stem after fall.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could not be established.The healthcare professional indicated there was a serious risk to the patient.There was 5 minutes 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 device history records (dhr) was not conducted since the item and or lot number was not provided or determined during the complaint evaluation.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 bent stem after fall.There was no information submitted with the complaint that would indicate a material, design, or manufacturing issues with the explanted parts.Should addition information become available this complaint shall be re-opened and a further evaluation well be conducted.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: ALTIVATE REVERSE SHOULDER
• Common Device Name: ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ6X175MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 8778036
• Report Number: 1644408-2019-00682
• Device Sequence Number: 19499616
• Product Code: PHX
• UDI-Device Identifier: 00888912168250
• UDI-Public: (01)00888912168250
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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 Model Number: 530-06-175
• Device Catalogue Number: 530-06-175
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/23/2019
• 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: 71 YR