MAUDE Adverse Event Report: ZIMMER GMBH REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 22/140; HIP IMPLANT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: biolox delta hd 12/14 32x+3.5, item#: 00877503203, lot #: 2648590.Revitan, proximal part, cylindrical, uncemented, 55, taper 12/14, item #: 0100402055 lot#: 2663273.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 the patient had a revision surgery due to the breakage of the implant approximately twelve (12) years after implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 22/140
• Type of Device: HIP IMPLANT
• 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: 18950126
• MDR Text Key: 338249468
• Report Number: 0009613350-2024-00120
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024592926
• UDI-Public: (01)00889024592926(17)140630(10)2515790
• 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,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 0100406122
• Device Lot Number: 2515790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2009
• 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): Required Intervention; Hospitalization