MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE REVERSE SHOULDER; ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X175MM

Model Number	533-08-175
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to these document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to loosening of humeral stem.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as loosening.The previous surgery and the surgery detailed in this event occurred 2 months apart.Initial or prolonged hospitalization was required.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 record (dhr) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was a non-conformance associated with the main part #533-08-175, altivate reverse, humeral stem, small shell, sz 8x175mm which documents that out of 15 parts lot, 1 part was rejected and scrapped by the vendor due to dimension out of tolerance.There was also and ncmr#: (b)(4) associated with the same part, documents that out of 15 parts lot, 3 parts were rejected due to uneven coating.Later the rejected parts were reworked and accepted after proper justification of standard pre-approved rework (spar).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 loosening.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 contribute to the event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, prolonged overhead activities, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: ALTIVATE REVERSE SHOULDER
• Common Device Name: ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X175MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9564389
• Report Number: 1644408-2019-01330
• Device Sequence Number: 2901607
• Product Code: KWS
• UDI-Device Identifier: 00190446259138
• UDI-Public: (01)00190446259138
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 12/13/2024
• Device Model Number: 533-08-175
• Device Catalogue Number: 533-08-175
• Device Lot Number: 927W1006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/24/2020
• 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: 508-32-103 LOT 864C3648.; 509-02-032 LOT 951W1264.; 533-08-000 LOT 004Y1000.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR