MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM; PROSTHESIS, HIP

Catalog Number	802403604
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 110010244; lot: 66519883; g7 osseoti 3 hole shell 52mm e.Cat: 010000999; lot: 7656399; g7 screw 6.5mm x 30mm.Cat: 010000983; lot: 7707569; g7 freedom const e1 lnr 36mm e.G2: foreign ¿ australia.H6: suggested component code: mechanical (g04) ¿ head.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately one and a half years post-implantation, the patient underwent a hip revision due to dislocation and acetabular implant breakage.Patient anatomy led to deformation of implant and dislocation.Attempts have been made and no further information has been provided.
Event or Problem Description
Upon receipt of additional information, it was determined that this report is a duplicate of (b)(4).The initial report was forwarded in error and should be voided.If additional information is to be received concerning the reported event, a supplemental mdr will be submitted under (b)(4).
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined that this report is a duplicate of (b)(4).The initial report was forwarded in error and should be voided.If additional information is to be received concerning the reported event, a supplemental mdr will be submitted under (b)(4).

• Brand Name: FREEDOM
• 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: 23309588
• Report Number: 0001822565-2025-03765
• Device Sequence Number: 17378663
• Product Code: LPH
• UDI-Device Identifier: 00889024499096
• UDI-Public: (01)00889024499096(17)330520(10)3158432
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 11/11/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 802403604
• Device Lot Number: 3158432
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Unknown