MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK CONTINUUM CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 10/27/2023

Event Type  Injury  

Event Description

It was reported in a journal article that the patient sustained a postoperative dislocation and was treated with stem and cup revision to correct excessive anteversion and inclination.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).G2: foreign ¿ iran.Reference: ravanbod, h., gharanizadeh, k., mirghaderi, p., hassan, a., and abolghasemian, m.(2023).Subtrochanteric shortening osteotomy provides superior function to trochanter slide osteotomy in tha for patients with unilateral crowe type iv dysplasia at a minimum of 3 years.Clinical orthopaedics and related research.Doi 10.1097/corr.0000000000002900.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.It is unknown what patient the pictures in the ja correlate to.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause cannot be determined.It was noted the cup had excessive inclination and anteversion which could have contributed to the dislocation.However, the placement of the cup is ultimately the surgeon's discretion in regards to what works best with the patient's anatomy.This complaint cannot be confirmed.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: UNK CONTINUUM CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19162386
• MDR Text Key: 340794326
• Report Number: 0001822565-2024-01354
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: IR
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention; Hospitalization