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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 11-107323 ¿ freedom liner ¿ 463300; 106054 ¿ shell ¿ 345600; 103200 - taperloc stem ¿ 143910.Customer has indicated that product will not be returned to zimmer biomet for the investigation as the product remains implanted at this time.The investigation is in process and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00378.
Event or Problem Description
It was reported that patient underwent a right hip revision approximately 3 months post implantation and a second revision approximately 13 years later.Subsequently, the patient reports experiencing a dislocation approximately 6 months after the second revision.A closed reduction was performed in the er.No additional revision surgery has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Reported event was confirmed by review of medial records noting that the patient presented to er due to hip dislocation.The er doc was able to get the hip relocated on the 2nd try.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FREEDOM CONSTR HD 36MM T1 -6MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11286076
• Report Number: 0001825034-2021-00379
• Device Sequence Number: 14338370
• Product Code: KWZ
• UDI-Device Identifier: 00880304203433
• UDI-Public: (01)00880304203433(17)281006(10)765640
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: 765640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Other
• Patient Weight: 83