MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM ALL POLY CUP 58MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 802403602 zb 12/14 cocr frdm 36mm x -3 lot number is 3050827.G2: foreign: australia.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure or trauma and can predispose the patient to infection.The development of a postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.Most hematomas resolve on their own, without surgical intervention, while some do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.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
It was reported that the patient underwent a revision procedure 17 days post implantation due to a hematoma.There is no additional information available at the time of this report.

• Brand Name: FREEDOM ALL POLY CUP 58MM
• 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: 17361906
• Report Number: 0001825034-2023-01696
• Device Sequence Number: 20121774
• Product Code: KWZ
• UDI-Device Identifier: 00880304203631
• UDI-Public: (01)00880304203631(17)210613(10)191580
• 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: 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
• Report Date (Section B): 07/18/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/13/2026
• Device Model Number: N/A
• Device Catalogue Number: 11-107126
• Device Lot Number: 191580
• 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: 07/07/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female