MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE REVERSE SHOULDER; AR, SMALL SOCKET INSERT, 44MM SEMI CONSTRAINED EPLUS

Model Number	509-03-044
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as fell and disassociation.The previous surgery and the surgery detailed in this event occurred 11 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 returned to manufacturer and examined by registered medical assistant (rma) at djo surgical.A review of the device history records (dhr) indicates that the parts were initially manufactured and the device labeling was found to have been released with an error in the sterilization method icon.The devices were subsequently reworked.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within expiration date at the time of the previous surgery.Review of the complaint history indicates that it is extremely unusual for a properly installed humeral insert to dissociate from the humeral stem.The root cause of this complaint cannot be determined.The patient's ongoing use of the device presumably resulted in extreme damage to the insert, obscuring possible evidence.Factors that may have contributed to this incident include pre-existing conditions of the patient including a possible seizure disorder, patient activity level and noncompliance with post-operative instructions, possible improper installation of the humeral insert, possible mislabeling, resulting in the implantation of a size 40 humeral insert instead of a size 44.Rma examination: the receipt of rma was delayed and misplaced for a period of time.When it was delivered to the complaints department, there was no documentation accompanying the part.Due to the unusual complaint description and the small number of open complaints pending return of an explant, the agent for this complaint was contacted with a photograph of the returned, damaged insert and asked to confirm that it was the insert he returned.It can be reasonably assumed that the part examined is the incident part, despite the loss of traceability.Review of the rma indicates that the part removed during surgery was a 509-03-044, ar, small socket insert, 40mm, +4 offset, semi constrained eplus.Due to the extensive damage resulting from the continued use after dissociation, the lot number is not legible.See attached photos.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Second revision surgery - patient fell on shoulder causing disassociation of the insert from the stem.The patient contacted the surgeon roughly 5 weeks later dislocated.The poly was extremely worn as it was loose from the disassociation.(no pieces left in patient).

• Brand Name: ALTIVATE REVERSE SHOULDER
• Common Device Name: AR, SMALL SOCKET INSERT, 44MM SEMI CONSTRAINED EPLUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 10560569
• Report Number: 1644408-2020-00789
• Device Sequence Number: 11468915
• Product Code: KWS
• UDI-Device Identifier: 00190446257684
• UDI-Public: (01)00190446257684
• 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: 2020
• 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): 09/21/2020

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: 12/07/2022
• Device Model Number: 509-03-044
• Device Catalogue Number: 509-03-044
• Device Lot Number: 964W1000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/21/2020
• 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: 508-44-101 LOT 877C1045
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR