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

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0001825034-2022-00117
• Device Sequence Number: 11899016
• Product Code: LPH
• UDI-Device Identifier: 00880304544444
• UDI-Public: (01)00880304544444(17)281118(10)6432610
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 55 KG