MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/140; HIP PROTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source - foreign: switzerland concomitant medical products: revitan, proximal part, cylindrical, uncemented, 55, taper 12/14, item#: 0100402055, lot#: 2985284.Biolox delta hd 12/14 36x+3.5, item#: 00-8775-036-03, lot#: 2986982.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 that the patient underwent hip revision due to a broken stem, approximately two (2) years and ten (10) months from initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d9, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided.Review of the manufacturing records identified no deviations or anomalies during manufacturing that could be related to the reported event.Device used for treatment.Patient is male, 163cm, 80kg (bmi 30.1), 62 years old at the moment of the event reported in this complaint.Radiographs were provided and reviewed by a health care professional (radiologist).An undated ap overview of the pelvis and an undated lateral view of the left hip were provided.The images are allegedly taken before the second revision surgery and show a medially tilted proximal part on the left hip most likely due to pin fracture of the revitan stem.On both images, periprosthetic lucency can be seen around the proximal part, laterally from the greater trochanter to the proximal subtrochanteric diaphysis, medially from the intertrochanteric region and only minimally into the subtrochanteric diaphysis.Products were not returned for examination.The patient was implanted with the shortest proximal part (size 55).This system configuration may lead to a more proximal location of the stem junction.The radiolucency shown in the provided x-rays suggests a possible loosening of the proximal part.Based on the literature, the proximal position of the modular connection, together with the loosening of the proximal part, increases the mechanical stresses on the taper and thus increases the risk for stem fracture.Other factors such as patient age, medical history, bmi and activity level, may have led or contributed to the reported event.In conclusion, based on the investigation a pin fracture of the distal revitan stem can be confirmed.Nevertheless, since the cause may be multifactorial, consisting of patient- and procedure-related factors, a definitive root cause could not be identified.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.

Event Description

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

• Brand Name: REVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/140
• Type of Device: HIP PROTHESIS
• 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: 16084667
• MDR Text Key: 306500803
• Report Number: 0009613350-2022-00681
• Device Sequence Number: 1
• Product Code: OQI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0100406120
• Device Lot Number: 3011208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 80 KG