MAUDE Adverse Event Report: ENCORE MEDICAL L.P HEAD, HUMERAL, OFFSET, 42-16; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	520-42-116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to pain.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2018-01156; 520-50-118, s807 - pain, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: HEAD, HUMERAL, OFFSET, 42-16
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18548490
• Report Number: 1644408-2023-02026
• Device Sequence Number: 13031814
• Product Code: KWS
• UDI-Device Identifier: 00888912025027
• UDI-Public: 00888912025027
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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): 01/19/2024

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: 03/02/2025
• Device Catalogue Number: 520-42-116
• Device Lot Number: 913C1164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2019
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 520-00-000 LOT: 878C1788
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male