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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a first stage revision of the left total hip arthroplasty approximately 1 month post implantation due to a bacterial infection.All components were removed.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 650-1064 ¿ ceramic taper ¿ 3064989, 650-1055 ¿ ceramic head ¿ 2020011173, 47249009700 ¿ tear drop guide wire ¿ 65316177, 166069 ¿ arcos screw ¿ 6828663, 166069 ¿ arcos screw ¿ 7032015, 166070 ¿ arcos screw ¿ 6970413, 166068 ¿ arcos screw ¿ 7053131, 166067 ¿ arcos screw ¿ 7197916.Report source: report source australia.Product will not be returned to zimmer biomet for the investigation as the product was discarded.The investigation is in process.Once the investigation as been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00092, 0001825034 - 2023 - 00093, 0001825034 - 2023 - 00094, 0001825034 - 2023 - 00095, 0001825034 - 2023 - 00096, 0001825034 - 2023 - 00097, 0001825034 - 2023 - 00098.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A radiograph was provided and reviewed by a health care professional.As the complaint is infection related the x-ray did not enhance the investigation.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.No device problem was found.Review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.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: 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: 16195424
• Report Number: 0001825034-2023-00091
• Device Sequence Number: 20326407
• Product Code: LPH
• UDI-Device Identifier: 00887868356056
• UDI-Public: (01)00887868356056(17)320301(10)7196541
• 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): 04/11/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010267
• Device Lot Number: 7196541
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 185 KG