MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 16X48MM

Catalog Number	530-16-048
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	08/26/2024
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
Revision surgery - due to implant broke and loosening.
Additional Manufacturer Narrative
See d3, d4 expiration date, g1, h6, h10 and h11.The agent reported "(stem was loose and baseplate center screw was broken.Replaced baseplate, screws, glenosphere and cemented a longer stem)".The previous surgery and the surgery detailed in this event occurred 1 year and 9 months apart.This evaluation is limited in scope as the items associated with this investigation were not returned to djo surgical - austin for review.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate the reported devices were defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.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.First, there was a nonconformance associated with the concomitant part #508-36-101, glenoid, head w/retaining screw, rsp, 36 mm, neutral which documents that out of 15 parts lot 1 part was rejected and scrapped during tap check stage.Second, there was an ncmr#62853 associated with the main part #530-16-048, altivate reverse, humeral stem, standard shell, sz 16x48mm which document that out of 15 parts lot 2 parts were rejected due to tape residue contamination in porous coating.Later, the rejected parts were reworked and accepted after proper justification.All other item in the 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.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.The root cause of this complaint was a revision surgery due to screw broken and stem loosening.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, prolonged overhead activities, inadequate soft tissue support, patient activities.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 16X48MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENOVRE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 20274346
• Report Number: 1644408-2024-01538
• Device Sequence Number: 7240559
• Product Code: KWS
• UDI-Device Identifier: 00190446334934
• UDI-Public: 00190446334934
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K190290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 12/05/2024

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 Catalogue Number: 530-16-048
• Device Lot Number: 1488A1047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2022
• 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: 506-03-114 LOT: 831C1963; 506-03-118 LOT: 832C2017; 506-03-122 LOT: 833C1833; 506-03-130 LOT: 835C1784; 508-32-204 LOT: 769P2379; 508-36-101 LOT: 869C3528; 509-00-436 LOT: 386P1243
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male