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

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent initial right total hip arthroplasty.The patient underwent a first revision approximately five months later due to dislocations and stem subsidence.Subsequently, patient underwent the second revision approximately 1 year and 3 months later due to dislocation, pain, and instability.The liner and head were exchanged without complications.The stem and cup remained implanted.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: ref 11-301302 lot 670970 cone.Ref 11-300917 lot 538950 stem.Ref 00-6250-065-40 lot j6983765 bone screw.Ref 00-6250-065-30 lot 64945767 bone screw.Ref 00-6250-065-20 lot 64776756 bone screw.Ref 00-2232-004-18 lot 64952454, 64443890 cerclage wires x2.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: dislocation occurred when bending over from wheelchair to pick and item off the ground.Presented with mild pain, aching, non-radiating, worse with movement.Instability s/p right total hip arthroplasty revision.Hip dislocated posteriorly, stem well fixed and remained intact, cup well fixed and remained intact.X-ray: dislocated right hip, no fracture, large amount of heterotopic bone.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02444.

• Brand Name: FREEDOM CONSTR HD 36MM T1 -6MM
• Common Device Name: PROSTHESIS, 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: 15690174
• Report Number: 0001825034-2022-02445
• Device Sequence Number: 12468023
• Product Code: KWZ
• UDI-Device Identifier: 00880304203433
• UDI-Public: (01)00880304203433(17)300812(10)620660
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2022

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: 11-107016
• Device Lot Number: 620660
• 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: 10/18/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• 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: Initial
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 57 KG