MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM CONSTR HD 36MM T1 -6MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure 9 months and 12 days post implantation due to a dislocation.Looking at the liner upon removal it was evident there was some damage that looked to be from levering.Surgeon was uncertain if it was a deficiency or if maximum leverage force was achieved that allowed this liner to be damaged/ for the hip to dislocate and be reduced.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 010000985 item name g7 freedom const e1 lnr 36mm g lot # 6771739.G2: foreign: canada.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: h6 suggested component code: mechanical (g04) - head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.The complaint cannot be confirmed.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
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; g3; h2; h3; h6; h10.H6: component code: mechanical (g04) - head.Product was returned and evaluated.Visual examination of the returned product identified that the head was returned seated in the liner.The spherical surface showed significant scratches on one side.The taper hole and rest of the spherical surface showed scratches from use.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause remains unchanged; a definitive root cause cannot be determined.The complaint remains unconfirmed.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 event information is available at the time of this report.

• Brand Name: FREEDOM CONSTR HD 36MM T1 -6MM
• Common Device Name: PROSTHETIC, 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: 19766462
• Report Number: 0001825034-2024-01866
• Device Sequence Number: 12913812
• Product Code: KWZ
• UDI-Device Identifier: 00880304203433
• UDI-Public: (01)00880304203433(17)320824(10)739420
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 06/11/2025

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 Model Number: N/A
• Device Catalogue Number: 11-107016
• Device Lot Number: 739420
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 06/10/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 10/08/2024; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown