MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 56F; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  malfunction  

Event Description

It was reported the g7 cup thread was damaged, therefore the inserter was unable to be removed during the surgery after implanted.Another cup was used.There was a twenty (20) minute delay.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d9; h2; h3; h6.G2 foreign: china.Visual examination of the returned product identified the threads in the center hole have been damaged.Due to the damage no further testing was completed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02371.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.

• Brand Name: G7 PPS LTD ACET SHELL 56F
• Type of Device: 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: 15401332
• MDR Text Key: 305683318
• Report Number: 0001825034-2022-02081
• Device Sequence Number: 1
• Product Code: OQG
• UDI-Device Identifier: 00880304524248
• UDI-Public: (01)00880304524248(17)310622(10)7045021
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000665
• Device Lot Number: 7045021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2021
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 82 KG