MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ENCORE HUMERAL SHOULDER STEM; ENCORE REVERSE SHOULDER HUMERAL STEM, PRIMARY, 42MM SHELL, SZ 14X108MM

Catalog Number	530-14-108
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - during the patient's initial surgery, the surgeon believed to have an adequate press-fit with his stem, but noticed instability at the patient's two week follow up.The stem did not look loose on the x-ray and the surgeon planned on exchanging the head and poly liner during the revision.During the revision surgery, the stem was found to be grossly loose and never achieved a press-fit in the original surgery.He cemented in a stem and implanted a new spacer, liner and head and the shoulder was stable.
Additional Manufacturer Narrative
The reason for this revision surgery was instability.The previous surgery and the revision detailed in this investigation occurred 14 days 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 device history records (dhr), shows that the reported components used in the previous surgery met design and manufacturing requirements.There were no ncmrs associated with the components that may have contributed to reported event.The device and its applicable concomitant devices were verified to have gone through acceptable sterilization processes and were within their respective expiration dates at the time of use during the previous surgery.The root cause of the instability was a loose stem.It was reported the stem was found to be grossly loose and had never achieved a press-fit in the original surgery.The surgeon cemented in the stem and implanted a new spacer, liner and head and the shoulder was stable.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.

• Brand Name: ENCORE HUMERAL SHOULDER STEM
• Common Device Name: ENCORE REVERSE SHOULDER HUMERAL STEM, PRIMARY, 42MM SHELL, SZ 14X108MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6304001
• Report Number: 1644408-2017-00050
• Device Sequence Number: 500676
• Product Code: PHX
• UDI-Device Identifier: 00888912168489
• UDI-Public: (01)00888912168489
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2017

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: 01/05/2022
• Device Catalogue Number: 530-14-108
• Device Lot Number: 415T1014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 03/22/2017
• 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: 508-36-101,LOT 869C1970; 509-01-436,LOT 390P1003; 510-08-000,LOT 142G1140
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR