MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEE H11 NARRATIVE; PROSTHESIS, SHOULDER

Catalog Number	110031407
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterile packaging had holes in it and there was plastic debris in the package.No adverse event has been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).D1: mini +10mm thickness +6mm taper offset 40mm diameter humeral tray.D10: cat: 110031407 lot: 64282516 mini +10mm thickness +6mm taper offset 40mm diameter humeral tray.Cat: 110031404 lot: 64263057 mini +10mm thickness +3mm taper offset 40mm diameter humeral tray.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d5, d9, g3, h2, h3, h6 the following section was corrected: h4 visual examination of the returned product and provided photos found the inner poly bag is damaged.Sterility is not considered breached.Additionally, debris was found in the sterile packaging.As the packaging was previously opened, the source of the debris could not be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device when it left zimmer biomet control is considered conforming to specification in regard to the damaged poly pouch.The root cause of the reported damaged poly bag can be attributed to transit damage.A definitive root cause could not be determined for the reported debris in sterile packaging, as the packing was previously opened.The reported event of damaged poly bag was confirmed by evaluation of the provided photos and returned product; the reported event of debris in the sterile packaging could not be confirmed.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 additional information to report at this time.

• Brand Name: SEE H11 NARRATIVE
• 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: 21218686
• Report Number: 0001822565-2025-00166
• Device Sequence Number: 14313206
• Product Code: KWS
• UDI-Device Identifier: 00887868231391
• UDI-Public: (01)00887868231391(17)290131(10)64282517
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110031407
• Device Lot Number: 64282517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/19/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2019
• 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: SEE H11 NARRATIVE.
• Patient Sex: Male