MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM CONSTR. LINER +5 SZ 24; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	11-107023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Sepsis (2067); Ambulation or Postural Difficulties (2544); Radiolucent Lines (4848); Aseptic loosening (4883)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent an initial left tha, with multiple revisions occurring after.The first revision due to dislocation, the second due to infection, where zimmer biomet devices were cemented and placed as spacers, and the third revision due to loosening and pain.The patient was noted to have been taking daily medication for pain and had difficulty ambulating.During the revision the cup and stem were grossly loose, but the infection was cleared.New devices were placed with no complications noted.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as related to off label use, as the surgeon used implants as spacer devices.It was also noted the shell was 'roughed up to create cement holes and grooves using a high-speed burr' likely indicating the cup was not meant to be cemented.As the cup used is unknown, the surgeon has used the g7 cup multiple times for this patient.Per the g7 acetabular system acetabular shells and accessories, 01-50-1231, it states that infection is an absolute contraindication.It was noted the brand of the head and liner are freedom.From the g7 freedom liner ifu, 01-50-1233 g7 acetabular system polyethylene acetabular liners it states also that infection is an absolute contraindication.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported the patient underwent a third left hip revision approximately 7 (seven) months post-implantation due to aseptic loosening.During the revision, the acetabular cup was found to be grossly loose and was removed without difficulty, and the femoral stem was also noted to be loose.Prior to the revision, the patient had an infection that was treated with irrigation and debridement, and the infection had cleared before the revision.The patient was revised with all implants exchanged without complications.Attempts have been made and no further information has been provided.

• Brand Name: FREEDOM CONSTR. LINER +5 SZ 24
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: 25216695
• Report Number: 0001825034-2026-01341
• Device Sequence Number: 9801454
• Product Code: KWZ
• UDI-Device Identifier: 00880304203525
• UDI-Public: (01)00880304203525(17)291125(10)66961702
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: Health Professional
• Device Catalogue Number: 11-107023
• Device Lot Number: 66961702
• 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: 05/05/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: White