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

Model Number N/A

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

Patient Problem Unspecified Infection (1930)

Event Date 09/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog#: 51-199341 sirius hip stem 44-d lot#: 747320, catalog#: 010000704 g7 bonemaster ltd acet shl 54f lot#: 3790870, catalog#: 650-0661 delta ceramic fem hd 36/0mm lot#: 2016050122.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: 0001825034-2019-04823 0001825034-2019-04824.

Event Description

It was reported that the patient developed a superficial infection approximately one month post implantation.Issue was resolved and patient remains implanted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Udi#: (b)(4).The event was confirmed with medical records received.Review of the available records identified the following: superficial infection & admitted to hospital, medication given ¿ unknown type prescribed, surgical intervention ¿ drainage of lesion of nec, no cultures provided, discharged and superficial infection resolved.Dhr was reviewed and no discrepancies relevant to the reported event were found.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

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

• 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: 9232868
• MDR Text Key: 164137049
• Report Number: 0001825034-2019-04825
• 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: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000858
• Device Lot Number: 3814661
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other