MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ENCORE SHOULDER; ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ8X108MM

Model Number	530-08-108
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to instability and pain.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as instability and pain.The previous surgery and the surgery detailed in this event occurred 3 months and 2 weeks apart.The actual in vivo time for the main part of the complaint is 3 years and 11 months from the primary surgery.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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was a ncmr# 44214 associated with the main part # 530-08-108, altivate reverse, humeral stem, standard shell, sz 8x108mm, which documents that out of 15 parts lot, 9 parts were rejected due to porous coating damaged around suture holes.Later the rejected parts were accepted to use as is after proper justification.All other items in the lot were met with the design, fit and function requirements.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to instability and pain.There were no findings during this evaluation that indicate the reported devices were defective.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 event.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Additional Manufacturer Narrative
Corrected data: see d.6a.Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: ENCORE SHOULDER
• Common Device Name: ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ8X108MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 15077238
• Report Number: 1644408-2022-00948
• Device Sequence Number: 12122398
• Product Code: PHX
• UDI-Device Identifier: 00888912168304
• UDI-Public: (01)00888912168304
• 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: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 07/06/2024
• Device Model Number: 530-08-108
• Device Catalogue Number: 530-08-108
• Device Lot Number: 406T1256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 506-03-118 LOT 832C1457; 506-03-118 LOT 832C1458; 506-03-126 LOT 834C1468; 508-36-103 LOT 871C1186; 509-01-036 LOT 382P1046
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female