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

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: 650-1058 cer bioloxd option hd 40mm lot #: 2982639.Item #: 650-1066 cer opt type 1 tpr sleve 0mm lot #: 2954544.Item #: 010000667 g7 pps ltd acet shell 60g lot #: 6421470.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right total hip arthroplasty.Subsequently, the patient underwent a revision of the head and liner due to infection four months later.The patient was released from the study due to explantation of the study device.Attempts were made to obtain additional information; however, none was available.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: a4, b4, b5, d4, g4, h2, h3, h4, h6.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Clinical notes were provided and reviewed.Patient under went right hip arthroplasty.No complications noted.1 month follow up shows no pain, legs equal, health score 80.3 month follow up shows health score 50, dissatisfied with implant/function.Hip aspirated due to pain.Irrigation and debridement with revision of head and liner due to deep infection, completed study due to explant of study device, discharged.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 further event information available at the time of this report.

• Brand Name: G7 NEUTRAL E1 LINER 40MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9279578
• MDR Text Key: 165088626
• Report Number: 0001825034-2019-04973
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

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: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000865
• Device Lot Number: 6406776
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 91