MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE ANATOMIC, OFFSET HUMERAL HEAD, 46X16; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	520-46-316
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
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
It was reported there was a 20 minute delay in surgery.
Additional Manufacturer Narrative
See d4 expiration date, d4 lot number, h4 and h11.The agent reported "(the surgeon was doing a subscap sparing anatomic total shoulder.The surgeon and scrub tech impacted the humeral head and neck together on the back table and then impacted to the humeral stem.The morse taper was checked and the implants were stable.When putting in the humeral stem and head in the patient as a monoblock when impacted with the black impactor the head disengaged from the neck and stem.This happened several times.He downsized the head and was able to impact with no further issues).".This event occurred during surgery, near the patient.The components were inspected prior to use and found acceptable.There was another suitable device available.The incident did cause a 20 min.Delay in surgery.There were broken/fragmented pieces left in the patient, but no specifics were reported.There was no risk or adverse event reported and the surgery was completed as intended.Surgical components condition can be determined while being used for its intended purpose.This does not indicate a product deficiency, failure, or issue.No further action is deemed necessary, at this time.A review of the device history record(s) show that the reported component(s) used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Complaint database review showed no previous complaints against item 520-46-316 lot no.957u1196, across all failure code categories.The root cause for this complaint is that the head disengaged from the neck and stem after impaction.There are multiple factors, that are outside of the control of djo surgical, which may have contributed to this event.One could be that the morse taper was not fully engaged.

• Brand Name: ALTIVATE ANATOMIC, OFFSET HUMERAL HEAD, 46X16
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19029781
• Report Number: 1644408-2024-00381
• Device Sequence Number: 7020377
• Product Code: PAO
• UDI-Device Identifier: 00190446176213
• UDI-Public: 00190446176213
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K162024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 520-46-316
• Device Lot Number: 957U1196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female