MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 12X48MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	530-12-048
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2018-00055; 530-14-108, s810 - device loosening, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Revision surgery - mdr - loosening.

• Brand Name: ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 12X48MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 18088687
• Report Number: 1644408-2023-01581
• Device Sequence Number: 12218205
• Product Code: KWS
• UDI-Device Identifier: 00190446334910
• UDI-Public: 00190446334910
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K190290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2023

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: 530-12-048
• Device Lot Number: 1486A1009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 509-00-432 , LOT 385P1189
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male