MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 32MM E; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Unspecified Infection (1930)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog#: 51-104120 tprlc 133 t1 pps ho 12x144mm 4mm t1 lot#: 6435533, catalog#: 110017332 g7 bispherical shell 52e lot#: 6531285, catalog#: 6501162 biomet biolox delta ceramic lot#: 2019011758.Report source: foreign: (b)(6).The device will not be returned for analysis as the device remains implanted; however, an investigation of the reported event is in progress.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: 0001825034-2019-04610.

Event Description

It was reported the patient underwent an initial hip replacement procedure.Subsequently, it was reported that the patient suffered wound leakage and possible infection approximately 3 weeks post implantation.The patient was admitted to hospital, the wound was superficially flushed in the operation room, and the patient was prescribed antibiotics.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.D4: udi#: (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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.

Event Description

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

• Brand Name: G7 NEUTRAL E1 LINER 32MM E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9176767
• MDR Text Key: 161968297
• Report Number: 0001825034-2019-04609
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

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: 03/21/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000849
• Device Lot Number: 6505040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 99