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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

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.

Event Description

It was reported from a clinical study that a patient had a revision surgery approximately twelve (12) years after implantation, due to pain and fracture of the femoral proximal body.During the revision, substantial metallosis was debrided from the joint, and the gluteal muscles were found detached from their origin.The proximal body was easily removed, and a transfemoral osteotomy was performed to remove the well-fixed distal portion.The initial cup and liner were retained, and the head and stem were replaced without complications.Cerclage wires were placed to stabilize the osteotomy.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated.Corrected.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• 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

• 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
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/21/2024
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male