MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM CONSTR HD 36MM T1 +9MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00625006525, bone screw selftapping 6.5 mm dia.25 mm length, lot# j7470733.00625006525, bone screw selftapping 6.5 mm dia.25 mm length, lot# j7470734 x3.110010267, g7 osseoti multihole 58mm g , lot # 7196532.11-301303, arcos con sz c std 60mm, lot #632650.11-301620, arcos 20x200mm cyl dist , lot # 032610.010000820, g7 hi-wall arcomxl lnr 36mm g, lot # 6588427.010000985, g7 freedom const e1 lnr 36mm g, lot # 7042237.G2: foreign: (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02169.0001825034 - 2023 - 02170.0001825034 - 2023 - 02172.0001825034 - 2023 - 02173.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device remains implanted.
Event or Problem Description
Me 9-14.It was reported that during a revision of unknown devices, the doctor noted that the acetabulum was not prepared correctly; therefore, inserted the cup with fixation of four screws.During the attempts of reduction, encountered difficulty and upon delivery of force, led to rotation of the press-fit femoral stem.A curved stem was then placed and as additional reduction attempts were made, the stem also rotated, leading to the stem being cemented.In the process of testing the hip, one event of dislocation occurred; therefore, additional reduction maneuvers were repeated.The procedure was completed and the patient was transported out of the or.After approximately 1 hour, the patient was returned to the or due to dislocation.The liner was revised to a freedom liner and was successfully reduced without dislocation.Subsequently, due to the use of tensile force, the cup detached from the acetabular wall and the patient was hospitalized hip pendent.There is no additional information available at the time of this report.
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/corrected updated: b4 g3 g6 h2 h6 component code: mechanical (g04) - head h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on evaluation of the provided x-rays.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: possible loosening of the acetabular cup and associated cement with lateral migration of the acetabular construct.Associated hip dislocation post revision.Loosening of the femoral component.A definitive root cause cannot be determined.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: FREEDOM CONSTR HD 36MM T1 +9MM
• 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: 17744741
• Report Number: 0001825034-2023-02174
• Device Sequence Number: 4236387
• Product Code: KWZ
• UDI-Device Identifier: 00880304203495
• UDI-Public: (01)00880304203495(17)300811(10)620700
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/05/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-107021
• Device Lot Number: 620700
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male