MAUDE Adverse Event Report: ZIMMER GMBH REVITAN BODIES; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: report source switzerland.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2024-00102.

Event Description

It was reported that patient underwent revision approximately 9 years post-implantation due to revitan fracture.The patient reported pain in the hip approximately 3 months ago, along with history of trauma to the right side, decreased ability to walk without a cane, and restriction of mobility and activities of daily living.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h11.Upon reassessment it was found that this device did not cause or contribute to the reported event.The initial report was forwarded in error.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 Description

Upon reassessment it was found that this device did not cause or contribute to the reported event.The initial report was forwarded in error.

• Brand Name: REVITAN BODIES
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18932383
• MDR Text Key: 338019623
• Report Number: 0009613350-2024-00104
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024503021
• UDI-Public: (01)00889024503021(17)200430(10)2808867
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K192236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 0100402075
• Device Lot Number: 2808867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male