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

Model Number 530-06-175

Device Problems Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 06/10/2019

Event Type  Injury  

Event Description

Revision surgery.Patient fell and bent the stem.

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
• Type of Device: 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
• MDR Text Key: 150621869
• Report Number: 1644408-2019-00682
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912168250
• UDI-Public: (01)00888912168250
• Combination Product (y/n): N
• PMA/PMN Number: K141990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR