MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 52MM E; PROSTHESIS, HIP

Catalog Number	110010244
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information is available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; d9; g3; h2; h3; h4; h6.Visual evaluation of the returned product found the packaging was previously opened.A hair-like fiber was found in the sterile packaging.As the product was returned opened, the source of the debris cannot be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Definitive root cause cannot be determined.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 trends.
Event or Problem Description
It was reported that during surgery, after the g7 cup was opened, that a hair was found folded inside the plastic bag containing the dome hole screw.There was no health consequences or impact reported.It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
Complaint # (b)(4).G2: foreign ¿ new zealand.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 52MM E
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24052627
• Report Number: 0001825034-2026-00114
• Device Sequence Number: 18605925
• Product Code: LPH
• UDI-Device Identifier: 00887868355882
• UDI-Public: (01)00887868355882(17)351028(10)67559199
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 110010244
• Device Lot Number: 67559199
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown