MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM CONSTR HD 36MM T1 +3MM; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Medical device site infection (4845); Joint effusion (4849)
Date of Event	09/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from a clinical study that a patient underwent a second stage right total hip arthroplasty followed by an incision and drainage with head and liner exchange.Subsequently, the patient presented to the emergency room with worsening pain.A ct scan showed a large fluid collection.The adverse event was classified as a deep joint infection.An aspiration was performed; however, no further information has been reported at this time.
Additional Manufacturer Narrative
(b)(4).D10: 110010249 g7 osseoti 4 hole shell 62mm h 66840592.010001001 g7 screw 6.5mm x 40mm j7009622.010000996 g7 screw 6.5mm x 15mm j7733805.11-300816 arcos 16x150mm spl tpr dist unknown.Unk liner unknown.Suggested component code- mechanical (g04): head.It was reported that no further information is available, therefore, no product identification information is available or was provided.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 from a clinical study that a patient underwent a second stage right total hip arthroplasty followed by an incision and drainage with stem, head and liner exchange.Subsequently, the patient presented to the emergency room with worsening pain.A ct scan showed a large fluid collection.The adverse event was classified as a deep joint infection.An aspiration was performed; however, no further information has been reported at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: a1; b5; d1; d2; d4; g3; g4; h2.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: presented to er with right hip pain worse with ambulation and movement, onset was one week prior, ct showed 16cm large right hip fluid collection.Classified as deep joint infection, no medical treatment reported.A review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.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 further information at the time of this report.

• Brand Name: FREEDOM CONSTR HD 36MM T1 +3MM
• Common Device Name: PROSTHESIS, HIPS
• 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: 23242915
• Report Number: 0001825034-2025-03125
• Device Sequence Number: 18720273
• Product Code: KWZ
• UDI-Device Identifier: 00880304203464
• UDI-Public: (01)00880304203464(17)330112(10)65710502
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2026

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 11-107019
• Device Lot Number: 65710502
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 02/10/2026; 03/17/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 03/05/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White