MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 18/200; HIP PROSTHESIS

Catalog Number 01.00406.218

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 09/05/2023

Event Type  Injury  

Event Description

It was reported that approximately six years post implantation, the patient underwent a revision surgery due to the fractured conical part of the distal curved stem.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10 - associated product: revitan, proximal part, cylindrical, uncemented, 95, taper 12/14; item# 01.00402.095; lot# 2838234.G2 - foreign: austria.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent a revision surgery six years post implantation due to a conical fracture of the distal part of the stem.During the revision, a trochanteric osteotomy was performed to remove the fractured stem.Cerclage wires were used to stabilize the osteotomy site.Granulation and osteolytic tissue was removed, and there was no indication of infection.The head, neck, and stem were replaced without complications.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10 - associated product: revitan, proximal part, cylindrical, uncemented, 95, taper 12/14; item# 01.00402.095; lot# 2838234; sulox-hd 32 m 12/14; item#17.32.06; lot # unknown.The revitan stem was returned for investigation with the ceramic head mounted on the taper.The ceramic head and the proximal part show normal signs of usage including damages from the revision surgery and are inconspicuous.On the anchoring surface of the distal part, there are revision damages in the form of scratches and nicks and only some isolated bone attachments.The connection pin of the distal part is fractured and the appearance of the fracture surfaces point to a fatigue fracture with the origin located on the lateral side.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.The available medical records were reviewed by a health care professional.The patient is male and was born in 1955.The patient underwent an initial right tha on an unknown date; as no medical record was provided for this procedure, it is unknown what products were implanted and what was the reason of the procedure.On (b)(6) 2017, the patient underwent a first revision surgery due to stem loosening; during the procedure the unknown cup was left in place, while the unknown stem, head and liner were replaced with zimmer biomet products.Possible signs of osteolysis of the acetabulum were noted.Subsequently, the patient underwent a second revision surgery on (b)(6) 2023 due to a fracture of the connection pin of the revitan stem.During the second revision, a trochanteric osteotomy was performed to remove the fractured stem and cerclage wires were used to stabilize the osteotomy site.Surgery notes report the presence of granulation and osteolytic tissue that could point to osteolysis; however, there was no indication of infection.The head, neck, and stem were replaced without complications.One ap x-ray of the right hip, allegedly taken before the second revision surgery, was provided.As the superimposed template partially obscures the image an assessment of the provided radiograph cannot be performed.The fracture of the connection pin of the distal revitan stem can be confirmed.The characteristics of the fracture surfaces point to a fatigue fracture.Based on the literature, factors such as patient age, weight, activity level and comorbidities (e.G.Osteolysis) may have led or contributed to the reported event.However, if and to what extend patient- and procedure-related factors may have contributed to the event remains unknown.Therefore, with the information provided, we are unable to provide a definitive conclusion as to the root cause of the reported issue.No corrective, preventive or field action was taken following the investigation of this event.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, DISTAL PART, CURVED, UNCEMENTED, 18/200
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 17835187
• MDR Text Key: 324491280
• Report Number: 0009613350-2023-00538
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024592964
• UDI-Public: (01)00889024592964(17)200930(10)2824548
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: N/A
• 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
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 01.00406.218
• Device Lot Number: 2824548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male