MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG E1 LINER 36MM G; PROSTHETIC, HIP

Model Number N/A

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

Patient Problems Pain (1994); Scar Tissue (2060)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 51-113140 item name tprlc 133 type1 bm so 14.0 lot # 6057581, 010000707 item name g7 bonemaster ltd acet shl 60g lot # 6332149.G2: foreign: australia multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02162, 0001825034 - 2023 - 02161.The device will not be returned for analysis as it remains implanted; 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 the patient underwent a revision procedure 7 months post implantation due to pain, possible poly disimpaction and instability.During the surgery, the poly was found intact and extensive scar tissue was debrided.Only the head was revised, and the procedure was completed without complication.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on evaluation of the provided medical records.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: x-ray review: there is no abnormal radiolucency or evidence of implant loosening.There is malalignment with subluxation/dislocation as noted.Records review: unstable, extensive scar tissue- debrided.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 10 DEG E1 LINER 36MM G
• 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: 17739786
• MDR Text Key: 323324076
• Report Number: 0001825034-2023-02160
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526785
• UDI-Public: (01)00880304526785(17)220203(10)3959772
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/31/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/03/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000898
• Device Lot Number: 3959772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 120 KG