MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 56MM F; PROSTHESISS, HIP

Model Number	N/A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Muscle/Tendon Damage (4532)
Date of Event	04/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 010000864 ¿ g7 liner ¿ 6544595, 650-1058 ¿ biolox ceramic head ¿ 2963349, 650-1065 ¿ biolox ceramic taper ¿ 2959057, 00625006515 ¿ bone screw ¿ 64492557, 00625006540 ¿ bone screw - 64302847, 192413 ¿ echo femoral stem ¿ 674160.Product will not be returning to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.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 -02590.
Event or Problem Description
It was reported that patient underwent a right hip revision approximately 6 years post implantation.Subsequently, the patient experienced instability and recurring dislocations a few months later.A small nondisplaced transverse acetabular fracture was noted on xray.The patient was revised again approximately 5 months later where impingement was noted as well as disruption of the previous capsular repair.The head and liner were removed and replaced.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.Reported event was confirmed via medical records/radiographs provided and reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no related deviations or anomalies during manufacturing.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 additional information on the reported event.

• Brand Name: G7 OSSEOTI MULTIHOLE 56MM F
• Common Device Name: PROSTHESISS, 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: 12432846
• Report Number: 0001825034-2021-02591
• Device Sequence Number: 14467293
• Product Code: LPH
• UDI-Device Identifier: 00880304544413
• UDI-Public: (01)00880304544413(17)290629(10)6578075
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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: 110010266
• Device Lot Number: 6578075
• 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: 08/13/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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; SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 72 KG