MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 70MM I; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360); Unequal Limb Length (4534); Insufficient Information (4580)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported the patient underwent an initial right hip arthroplasty on an unknown date.Subsequently, the patient plans to be revised due to an unknown reason.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported a patient had a revision of a right hip prosthesis.Subsequently, approximately two weeks later, radiographic imaging displayed dissociation of the cup from the pelvis and ¿huge¿ pelvic defects.Upon follow-up, the patient reports having severe pain and assessment indicated that the right leg was shortened.A pmi product is currently being planned for the patient¿s next revision.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Investigation codes updated.Investigation summary results remain unchanged and no new information to report at this time.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.Review of the available records identified the following:xrays show displaced cup from recent surgery and the cup is disassociated  from the acetabulum.  bone quality is severely osteopenic which could contribute to this complication.There is no evidence of trauma ct showed dissociation of pelvis.  her leg is neurovascular intact, shortened on right side.Large pelvic defect, with high pain.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: G7 OSSEOTI MULTIHOLE 70MM I
• Common Device Name: PROSTHESIS, HIPS
• 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: 17995377
• Report Number: 0001825034-2023-02475
• Device Sequence Number: 12180464
• Product Code: LPH
• UDI-Device Identifier: 00887868356117
• UDI-Public: (01)00887868356117(17)280620(10)6307341
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/14/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 110010273
• Device Lot Number: 6307341
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 11/07/2023; 01/03/2024; 03/12/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/29/2023; 01/04/2024; 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2018
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 107 KG