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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 10/16/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: report source germany.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a revision surgery due to a revitan cone that was broken during removal of the shaft component; oblique fracture of the femur.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4): d6a: product implanted on an unknown date in 2018.The revitan stem was returned for investigation and the connection pin of the distal stem is fractured.No bone ongrowth can be seen on the anchoring surface of the proximal part; on the medial, anterolateral and posterolateral side, polished spots and lines are visible, indicating possible loosening and movement against the bone.The characteristics of the fracture surfaces point to a fatigue fracture with the origin located on the lateral side.The proximal end of the distal part displays scratching and wear on the face surface as well as on the posterior flank.Bone attachments can be found on the anchoring surface of the distal part especially on the medial side.All around the distal part, signs of wear with a circumferential pattern are visible most likely caused by an instrument during revision surgery.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and the part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Based on the investigation, a fracture of the connection pin of the revitan stem can be confirmed.The characteristics of the fracture surfaces point to a fatigue fracture.The cause may be multifactorial, consisting of patient- and procedure-related factors.Nevertheless, with the information provided, we are unable to provide further analysis of the complaint reported or draw any definitive conclusions as to the root cause of the reported issue.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.

• Brand Name: REVITAN STEMS
• 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: 18138762
• MDR Text Key: 328118394
• Report Number: 0009613350-2023-00625
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024592933
• UDI-Public: (01)00889024592933(17)200131(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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2024
• 2 Devices were Involved in the Event: 1 2

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: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 0100406120
• Device Lot Number: 2786473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 02/08/2024; 04/18/2024
• Supplement Dates FDA Received: 03/05/2024; 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2015
• 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
• Treatment: REVITAN®, PROXIMAL PART, CYLINDRICAL.; UNKNOWN HEAD.; UNKNOWN PROXIMAL REVITAN COMPONENT.
• Patient Outcome(s): Hospitalization; Required Intervention