MAUDE Adverse Event Report: ZIMMER GMBH REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 20/140; HIP PROTHESIS

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 11/05/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: revitanâ®, proximal part, cylindrical, uncemented, 65, taper 12/14 item # 0100402065 lot # 2799951 g2: foreign: germany.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 Description

It was reported that there was a surgery revision due to pain caused by a cone fracture at the p part of curved stem connection.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon reassessment of the reported event, it was identified as a duplicate case, the reportability will be completed in mdr349489 (mrf report number: 0009613350 - 2023-00636).The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was identified as a duplicate case, the reportability will be completed in mdr349489 (mrf report number: 0009613350 - 2023-00636).The initial report was forwarded in error and should be voided.

• Brand Name: REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 20/140
• Type of Device: HIP PROTHESIS
• 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: 18307522
• MDR Text Key: 330221530
• Report Number: 0009613350-2023-00688
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024592933
• UDI-Public: (01)00889024592933(17)141209(10)2786473
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 0100406120
• Device Lot Number: 2786473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2014
• 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
• Treatment: SEE NARRATIVE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male