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

Catalog Number	110010267
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Erosion (1750); Osteolysis (2377)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left hip procedure approximately nine months¿ post implantation due to osteolysis and loosening.During the procedure, bone loss was noted, the shell was removed and replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Report source: australia.Concomitant medical products: cat #: 31-323240/3.2mmx40mm rnglc+ acet drl bit/ lot #: 614350 cat #: ep-200152/act artic e1 hip brg 28x46mm/ lot #: 735920 cat #: 110024465/g7 dual mobility liner 46mm g/ lot #: 492650 cat #: 00625006550/bone screw self-tapping 6.5 mm dia.50 mm length/ lot #: 63794457.Cat #: 00625006520/bone screw self-tapping 6.5 mm dia.20 mm length/lot #: 64615051.Cat #: 00625006520/bone screw self-tapping 6.5 mm dia.20 mm length/lot #: j6963834.Cat #: 00625006540/bone screw self-tapping 6.5 mm dia.40 mm length/lot #: j6923630.Cat #: 00625006525/bone screw self-tapping 6.5 mm dia.25 mm length/lot #: j6925770.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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: 15870981
• Report Number: 0001825034-2022-02660
• Device Sequence Number: 15128250
• Product Code: LPH
• UDI-Device Identifier: 00887868356056
• UDI-Public: (01)00887868356056(17)311013(10)7121443
• 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: 2022
• 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): 02/14/2023

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 Catalogue Number: 110010267
• Device Lot Number: 7121443
• 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: 11/02/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female