MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM ALL POLY CUP 50MM; PROSTHESIS, HIP

Catalog Number	11-107122
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00772, 0001825034-2023-00599.Report source: australia.Concomitant medical products: cat #: 802403204/ constrained head 12/14 taper 32 mm diameter +6 mm neck length for use with freedom constrained liners/ lot #: 3014471, cat #: 010000980/ g7 freedom const e1 lnr 32mm b / lot: 6374731.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that there was a revision due to a dislocation.The cup, liner and head were replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Upon reassessment of the reported event, it was determined that this device did not contribute to nor was involved in the event.The initial report should be voided.
Event or Problem Description
Upon reassessment of the reported event, it was determined that this device did not contribute to nor was involved in the event.The initial report should be voided.

• Brand Name: FREEDOM ALL POLY CUP 50MM
• 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: 16582363
• Report Number: 0001825034-2023-00600
• Device Sequence Number: 1635488
• Product Code: KWZ
• UDI-Device Identifier: 00880304203587
• UDI-Public: (01)00880304203587(17)260621(10)803380
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/13/2023

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 Expiration Date: 06/21/2026
• Device Catalogue Number: 11-107122
• Device Lot Number: 803380
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female