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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)

Event Date 12/15/2023

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).D10.Cobalt-chrome head 36 mm item#uknonwn lot#unknown revitanâ®, proximal part, conical, uncemented, 85, taper 12/14 item#0100401085 lot#2627253 unk wire cerclage ¿ proximal & distal unk acetabular cup unk liner g2.Report source: 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 3500a will be submitted.

Event Description

It was reported a patient had an initial right total hip arthroplasty in (b)(6) 2014 followed by a revision in (b)(6) 2015 due to loosening.Subsequently, began to experience pain and approximately 2 months ago, underwent a revision where metallosis was encountered and the stem was found fractured within the cone area, at the connection site.All implants were revised without complication.Diligence is complete and to date no additional information is available.

• Brand Name: REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 20/140
• 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: 18730418
• MDR Text Key: 335722691
• Report Number: 0009613350-2024-00050
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 0100406120
• Device Lot Number: 2627253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2011
• 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 H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 89 KG