MAUDE Adverse Event Report: ENCORE MEDICAL LP ALTIVATE REVERSE SHOULDER; ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 8X108MM

Model Number	530-08-108
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Second revision surgery - due to periprosthetic fracture.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as fracture.The previous surgery and the surgery detailed in this event occurred 3 years and 10 months 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 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.At first there was an ncmr-35383 associated with the main part #530-08-108 altivate reverse, humeral stem, standard shell, sz 8x108mm which documents that out of 15 parts lot, all were rejected due to coating does not fall within profile.Later the rejected parts were reworked and accepted after proper justification.Secondly, there was an ncmr-36502 associated with the same part which documents that out of 15 parts lot, 2 parts were rejected.Out of that, one part was scrapped due to out of tolerance and other part was found no defect in porous coating and accepted after proper justification.All other items in the respective lot were met with fit, form 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 fracture.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, patient bone deterioration, prolonged overhead activities, 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.

• Brand Name: ALTIVATE REVERSE SHOULDER
• Common Device Name: ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 8X108MM
• Manufacturer (Section D): ENCORE MEDICAL LP; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 11732022
• Report Number: 1644408-2021-00346
• Device Sequence Number: 3591246
• Product Code: PHX
• UDI-Device Identifier: 00888912168304
• UDI-Public: (01)00888912168304
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• 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): 06/01/2021

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: 03/23/2023
• Device Model Number: 530-08-108
• Device Catalogue Number: 530-08-108
• Device Lot Number: 406T1094
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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: 508-44-101 LOT 877C1030; 509-01-444 LOT 392P1006; 510-08-000 LOT 142G1194; 508-44-101 LOT 877C1030; 509-01-444 LOT 392P1006; 510-08-000 LOT 142G1194
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR