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

Catalog Number 010000859

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/11/2019

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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 -04397, 0001825034 - 2019 -04398, 0001825034 -2019 -04403, 0001825034 -2019 - 04405.Concomitant medical products: item # 010000666- g7 pps ltd acet shell-lot # 3509228, item # 51-107140- taper lock stem ¿lot #3652997, item #650-1067-biolox ceramic taper lot# 562710, item# #650-1057 biolox ceramic head lot #282670.

Event Description

It was reported patient underwent r hip revision approximately 2 years post implantation due to unknown reasons.All components were removed and replaced.Attempts have been made and additional information is not available at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 G
• Type of Device: HIP PROSTESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9180316
• MDR Text Key: 162438576
• Report Number: 0001825034-2019-04396
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2021
• Device Catalogue Number: 010000859
• Device Lot Number: 3776796
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2019
• 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