MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FREEDOM CONST E1 LNR 36MM G; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 7 months post implantation, the patient underwent a revision due to dislocation.Attempts have been made and no further information has been made available.
Additional Manufacturer Narrative
(b)(4).D10: 802403603 constrained head 12/14 taper 36 mm diameter +0 mm neck length for use with freedom constrained liners 3041611.G2: foreign: australia.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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 related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.Unable to confirm complaint as no product was returned or medical records were provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: G7 FREEDOM CONST E1 LNR 36MM G
• Common Device Name: PROTHESIS, 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: 18345481
• Report Number: 0001825034-2023-03010
• Device Sequence Number: 6203199
• Product Code: PBI
• UDI-Device Identifier: 00880304989092
• UDI-Public: (01)00880304989092(17)250317(10)6771746
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• 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): 03/14/2024

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: Lay User/Patient
• Device Expiration Date: 03/17/2025
• Device Model Number: N/A
• Device Catalogue Number: 010000985
• Device Lot Number: 6771746
• 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: 11/24/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male