MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 62MM H; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problems Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 00625006525-bone screw self-tapping 6.5 mm dia.25 mm length-64109373; 00625006530-bone screw self-tapping 6.5 mm dia.30 mm length-64246317; 00625006540-bone screw self-tapping 6.5 mm dia.40 mm length-64348073; 00625006550-bone screw self-tapping 6.5 mm dia.50 mm length-63481149; unknown-depuy trilock femoral stem-unknown ; 010000749-g7 neutral arcomxl lnr 40mm h-6406911.Reported event was confirmed via medical records reviewed by a health care professional.A review of the available records identified findings of the reported issues aseptic loosening found 6 weeks post op, pain, multiple fractures with functional discontinuity, as reported.Migration of the acetabular component with a new onset of pain consistent with mechanical loosening.Acetabular component was found to be mobile and toggling about the ilium screws which did not demonstrate they loosened.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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

It was reported patient underwent a left hip revision approximately 2 months¿ post implantation due to migration of the acetabular component on radiographs and new onset of pain consistent with mechanical loosening.During the revision, two cups were placed with augments and cement to create one construct.A dual mobility was placed, and the competitor stem was retained.No further event information available at the time of this report.

• Brand Name: G7 OSSEOTI MULTIHOLE 62MM H
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13289115
• MDR Text Key: 284012922
• Report Number: 0001825034-2022-00117
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304544444
• UDI-Public: (01)00880304544444(17)281118(10)6432610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2022

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010269
• Device Lot Number: 6432610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 55 KG