MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR SYSTEM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Markings/Labelling Problem (2911); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the package was opened, it was noticed that the internal sterile pack and external sterile pack were seemingly heat-shrunk.The inner package was welded to the external package.The outside of the box also had blurred/smeared writing.There was no known impact or consequences to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6.Visual evaluation of the provided photos and the returned product found the sterile packaging exhibits damage that is visually consistent with thermal damage.The barcode on the label is smeared and both cavities are deformed.Additionally, the tyvek lid was lifted on both the inner and outer blister compromising sterility.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The condition of the device when it left zimmer biomet control is considered non-conforming to specification.The root cause of the reported event can be attributed to a manufacturing issue.This complaint was confirmed by evaluation of the provided photos and returned product.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.

• Brand Name: G7 ACETABULAR SYSTEM
• Common Device Name: PROSTHESIS, HIP
• 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: 21138184
• Report Number: 0001822565-2025-00105
• Device Sequence Number: 6982635
• Product Code: LPH
• UDI-Device Identifier: 00889024519916
• UDI-Public: (01)00889024519916(17)290820(10)66855114
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• 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): 05/15/2025

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 Model Number: N/A
• Device Catalogue Number: 30103606
• Device Lot Number: 66855114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2024
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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
• Patient Sex: Male