MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 40MM F; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Muscle/Tendon Damage (4532)

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 110010266 - g7 multihole shell - 6578075, 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 -02591.

Event 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h4; h6.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 Description

No additional information on the reported event.

• Brand Name: G7 NEUTRAL E1 LINER 40MM F
• Type of Device: 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: 12432860
• MDR Text Key: 270076636
• Report Number: 0001825034-2021-02590
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526488
• UDI-Public: (01)00880304526488(17)240506(10)6544595
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000864
• Device Lot Number: 6544595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 72 KG