MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 6X108MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	533-06-108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - mdr - loosening/instability - patient was experiencing instability.Primary humeral stem was found to be loose by surgeon and was removed.A larger stem (8 x 108) was cemented in place.Surgeon removed these implants from primary surgery and replaced with new.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2019-00134; 533-10-108, s810 - device loosening, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 6X108MM
• 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: 18288869
• Report Number: 1644408-2023-01777
• Device Sequence Number: 5910442
• Product Code: KWS
• UDI-Device Identifier: 00190446259091
• UDI-Public: 00190446259091
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K172351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/07/2023

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: 533-06-108
• Device Lot Number: 923W1085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2019
• 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: 415-00-080 , LOT 7720281; 508-32-103 , LOT 864C4423; 509-02-032 , LOT 951W1543
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female