MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 8X108MM

Catalog Number	530-08-108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint - due to the poly was extremely difficult to impact into the stem.Took him more than 10 impacts to fully seat it.
Additional Manufacturer Narrative
The agent reported "dr green stated that the poly was extremely difficult to impact into the stem.Took him more than 10 impacts to fully seat it." this event occurred during assembly of components, near the patient.Significant adverse event was reported by the surgeon.There was a 3-5 minute delay in surgery, but the surgery was completed as intended.The device was inspected prior to use and found to be acceptable.The agent was present during the event and was able to provide another suitable device.Rma examination: the reported devices were not returned to surgical for evaluation.The product feedback form indicates the device was left in the patient.If at a later time the devices are returned an amendment will be opened.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 ncmr-70500 for 530-08-108, altivate reverse humeral stem standard shell, which document that out of 15 parts lot, 15 part was rejected due burrs around the suture holes from excessive porous and tape residue.Later, the rejected parts were reworked and accepted after proper justification.All other items in the lot met 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 surgery.There have been no other complaints reported against the reported lot numbers.9 socket inserts have been consumed with no complaints 6 humeral stems have been consumed with no complaints.There's been 1 other similar complaint for this surgeon.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The surgery was completed successfully.The root cause of this complaint is likely due to bone or tissue interference.This is not an event due to the product malfunction or failure.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 8X108MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 20605300
• Report Number: 1644408-2024-01735
• Device Sequence Number: 12596827
• Product Code: HSD
• UDI-Device Identifier: 00888912168304
• UDI-Public: 00888912168304
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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: 530-08-108
• Device Lot Number: 406T1583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2024
• 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: 509-00-036 LOT: 378P1705
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male