MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 58MM G; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a hip arthroplasty.The patient was revised approximately 2 years post hip resurfacing due to loosening of acetabular cup.No additional information.
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: cat # ep-200152 lot # 956960 act artic e1 hip brg 28x46mm, cat # 110024465 lot # 493790 g7 dual mobility liner 46mm g, cat # 010000997 lot # 6675889 g7 screw 6.5mm x 20mm, cat # 010001003 lot # 660126 g7 screw 6.5mm x 50mm.Foreign: country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, h2, h3, h6 reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: impressions: loosening of the acetabular implant of the left hip.Device history record (dhr) was reviewed and no discrepancies were found.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
No further event information available at the time of this report.

• Brand Name: G7 OSSEOTI MULTIHOLE 58MM G
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15894286
• Report Number: 0001825034-2022-02597
• Device Sequence Number: 5258068
• Product Code: LZO
• UDI-Device Identifier: 00887868356056
• UDI-Public: (01)00887868356056(17)300519(10)6789439
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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: 110010267
• Device Lot Number: 6789439
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 64 KG