MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Item # 51-107120, stem, lot # 3661685.Item # 12-115121, head, lot # 741740.Item # 110017105, shell, lot # 3667674.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05706; 0001825034 - 2018 - 05707; 0001825034 - 2018 - 05708.

Event Description

It was reported that approximately 1 month post implantation, the patient continued to have complaints of drainage after an i&d was performed.Deep aspiration revealed (b)(6) infection.Patient thus underwent radical debridement, soft tissue debridement, and insertion of temporary prostalac antibiotic lading spacer, with a two-stage revision, and re-implantation of permanent devices.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of revision operative notes received.Revision operative notes stated the cup, head, spacer stem, and cement were removed.G7 cup, liner, delta head and arcos modular stem were implanted.Super cable was used to fix trochanter.No complications noted during procedure.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

• Brand Name: G7 NEUTRAL E1 LINER 36MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7761947
• MDR Text Key: 116396382
• Report Number: 0001825034-2018-05709
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

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: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000858
• Device Lot Number: 3645923
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 93