MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 52MM E; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02455, 0001822565-2021-02306, 0001822565-2021-02311.
Event or Problem Description
It was reported that approximately 23 days post implantation, the patient experienced delayed wound healing requiring a fine needle aspiration of the joint.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Approximately 3 weeks postop, the patient was found to have delayed/altered wound healing.An aspiration of the joint was performed, and the patient was placed on oral antibiotics.The aspiration results were negative for infection, and by the 1 month postop visit, the incision was demonstrating progressive healing without further complication.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression wound concerns or non-healing wound would imply that the appearance of the wound deviates from what a surgical wound should appear as.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.This deviation signifies an alteration in the wound healing process.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records will not be performed.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 that approximately 23 days post implantation, the patient experienced delayed wound healing requiring a fine needle aspiration of the joint.Results were negative for deep infection, oral antibiotics were completed, and the incision is healing as expected at the most recent follow up.No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 52MM E
• 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: 12342268
• Report Number: 0001825034-2021-02456
• Device Sequence Number: 20954785
• Product Code: LPH
• UDI-Device Identifier: 00887868355882
• UDI-Public: (01)00887868355882(17)301205(10)64911675
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2023

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: 110010244
• Device Lot Number: 64911675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 08/04/2021; 08/04/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 08/31/2021; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2020
• 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: CAT#: 00877502801 BIOLOX TAPER LOT#: 3052505.; CAT#: 110024463 G7 LINER LOT#: 959530.; CAT#: 110031011 VIVACIT-E BEARING LOT#: 64934223.; CAT#: 574101010 AVENIR COMPLETE LOT#: 3048528.; CAT#: 00877502801 BIOLOX TAPER LOT#: 3052505; CAT#: 110024463 G7 LINER LOT#: 959530; CAT#: 110031011 VIVACIT-E BEARING LOT#: 64934223; CAT#: 574101010 AVENIR COMPLETE LOT#: 3048528
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female
• Patient Weight: 61 KG