MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SIZE 10 STANDARD HUMERAL STEM; PROSTHESIS, SHOULDER

Catalog Number	SAHS1110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a study that a patient developed a bloody drainage from the inferior wound and was placed on antibiotics as a preventative measure as there was no concern for infection.The incision has continued to heal with no further complications reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: 4 peg mod glen lt aug sz 4, cat #: sagl2144, lot #: 65891314.Trabecular metal modular post, cat #: sagp0002, lot #: 66408827.48mm x 17mm humeral head, cat #: sahh4817, lot #: 65628080.Humeral head adapter, cat #: sahha001, lot #: 66233299.135 humeral stem adapter, cat #: sahaf135, lot #: 65943624.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10, h11.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression ¿wound concerns¿ or ¿non-healing wound¿ would imply that the appearance of the wound deviates from what a surgical wound should appear.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.This deviation signifies an alteration in the wound healing process which can be complicated by patient comorbidities such as diabetes, obesity, smoking, and other conditions that are known to slow a person¿s ability to heal.Wound complications can be treated conservatively or more invasively with an irrigation and debridement (i&d) which promotes healing at the site and prevents further complications.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: SIZE 10 STANDARD HUMERAL STEM
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19982937
• Report Number: 0001822565-2024-02655
• Device Sequence Number: 11453280
• Product Code: MBF
• UDI-Device Identifier: 00889024627079
• UDI-Public: (01)00889024627079(17)331031(10)66328554
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K213856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: Lay User/Patient
• Device Catalogue Number: SAHS1110
• Device Lot Number: 66328554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2023
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 147 KG