MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FINNED 4 HOLE SHELL 54F; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peripheral Nervous Injury (4414)
Date of Event	09/12/2018
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 is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02415, 0001825034 - 2021 - 02416, 0001825034 - 2021 - 02417.
Event or Problem Description
It was reported a patient had a left hip revision.Per legal allegations, as a result of the surgery, patient developed a problem with her left foot that was diagnosed as a left deep peroneal nerve injury causing her foot to drop and seriously limiting her ability to walk and stand.No further intervention or medical records have been provided.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.No product was returned; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp) 'as a result of the previous surgery, patient developed a problem with her left foot that was diagnosed as a left deep peroneal nerve injury causing her foot to drop and seriously limiting her ability to walk and stand.' no change in condition with treatment or passing of time.Now permanent and impaired work and daily activities part and lot identification are necessary for review of device history records, neither were 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
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 available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues left foot drop peroneal nerve injury, limited ability, walk and stand.No change in conditions with treatment or time.Now permanent and impairing work and daily activity.Device history record was reviewed and no discrepancies relevant to the reported event were found.No change to root cause from previous investigation.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 FINNED 4 HOLE SHELL 54F
• 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: 12331027
• Report Number: 0001825034-2021-02414
• Device Sequence Number: 2754434
• Product Code: PBI
• UDI-Device Identifier: 00880304672116
• UDI-Public: (01)00880304672116(17)280614(10)6307966
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/24/2022
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110017104
• Device Lot Number: 6307996
• 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: 07/29/2021
• Supplement Date Received by Manufacturer: 08/17/2021; 04/01/2022; 04/28/2022; 05/20/2022
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 08/19/2021; 04/19/2022; 05/20/2022; 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2018
• 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: Disability
• Patient Sex: Female
• Patient Weight: 109 KG