MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 32MM F; PROSTHETIC, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994)

Event Date 04/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: foreign: netherlands.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02669; 0001825034 - 2023 - 02670; 0001825034 - 2023 - 02673.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device remains implanted.

Event Description

It was reported that 9 years post implantation, the patient fell resulting in pain.There is no additional information available at the time of this report.

Event Description

It was reported that 9 years post implantation, the patient tripped over the sidewalk in a hurry resulting in a fall landing on her left shoulder and left side of her head.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

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.Complaint confirmed based on the evaluation of the provided medical records.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient reported to ed she tripped over the sidewalk in a hurry.Landed on left shoulder and left side of head, no loss of consciousness, no amnesia.Examination of the left shoulder in 2 directions.Normal bone structure.Comminuted proximal humeral fracture on the left involving avulsion and diastasis of the greater tubercle fragment.No significant humeral head rotation component.Some enclave.Otherwise intact osseous structures.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 Description

There is no update to the prior event description provided.

• Brand Name: G7 NEUTRAL E1 LINER 32MM F
• Type of Device: PROSTHETIC, 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: 18168811
• MDR Text Key: 328526707
• Report Number: 0001825034-2023-02671
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/13/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000850
• Device Lot Number: 3401496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10.
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose