MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE SHOULDER; ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ12X108MM

Model Number	530-12-108
Health Effect - Clinical Code	Fracture, Arm (2351)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was due to a fracture.The previous surgery and the revision detailed in this investigation occurred over 2 years and 1 month apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There was a non-conformance associated with the part 530-12-108, encore reverse shoulder humeral stem, standard, size 12x108 millimeter that out of 15 quantity lot, 1 item was rejected and scrapped due to ml02 (material defect) part was bent.All other 14 items were accepted.All other items in the lot met the design, fit and function requirements.The device and its applicable concomitant devices were within their respective expiration dates at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to a fracture.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event.There are multiple factors that may contribute to fracture that are outside the control of djo surgical such as: poor bone density, patient noncompliance with medical instruction, patient activities or trauma.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - due to the patient suffering a fracture in her humerus after her primary shoulder surgery.It was decided by the surgeon and patient that a revision surgery was needed to take out the primary humeral stem and put a longer stem in that would reduce the fracture.A successful revision of the humeral stem components and glenoid head was performed.

• Brand Name: ALTIVATE SHOULDER
• Common Device Name: ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ12X108MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8493362
• Report Number: 1644408-2019-00283
• Device Sequence Number: 16398604
• Product Code: HSD
• UDI-Device Identifier: 00888912168427
• UDI-Public: (01)00888912168427
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2019

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: 07/22/2022
• Device Model Number: 530-12-108
• Device Catalogue Number: 530-12-108
• Device Lot Number: 412T1054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR