MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIT E NEUTRAL LNR 36MM D; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Cat# 010000662 lot# 6886707 g7 pps ltd acet shell 50d.Cat# 010000999 lot# 6825839 g7 screw 6.5mm x 30mm.Cat# 192510 lot# 827220 echo por fem red lat nc 10x130.Cat# 12-115121 lot# 2986081 cer bioloxd mod hd 36mm std nk.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 that the patient underwent a left hip arthroplasty.Subsequently, the patient is being considered for a pmi product on an unknown day due to dislocation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: all of the provided images demonstrate anatomic alignment of the total hip arthroplasty which appears intact and demonstrates no periprosthetic lucencies.No signs of dislocation noted.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 information at the time of this report.

• Brand Name: G7 VIT E NEUTRAL LNR 36MM D
• 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: 17470238
• Report Number: 0001825034-2023-01804
• Device Sequence Number: 12542921
• Product Code: LPH
• UDI-Device Identifier: 00889024519893
• UDI-Public: (01)00889024519893(17)250630(10)64780117
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 30103604
• Device Lot Number: 64780117
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown