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

Model Number N/A

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

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: unknown ¿ unknown stem ¿ unknown; 12-115120 ¿ biolox delta modular ceramic head ¿ 969560; unknown ¿ unknown shell ¿ unknown; therapy date: (b)(6) 2016.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product 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 - 2018 - 06971; 0001825034 - 2018 - 06974.

Event Description

It was reported patient underwent irrigation and debridement of hematoma and wound revision approximately 1 month post right primary total hip arthroplasty.Subsequently, patient underwent a two stage revision approximately 2 months post implantation due to infection with permanent devices being implanted approximately 1 month after that.The head, liner and shell components were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed by review of medical records.Medical records revealed that the patient had the liner, head, and shell revised due to drainage and infection.Review of the device history record identified no deviations or anomalies would contribute to reported event.Root cause was unable to be determined with the information 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.(udi) : (b)(4).

• Brand Name: G7 NEUTRAL E1 LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7763337
• MDR Text Key: 116449723
• Report Number: 0001825034-2018-06986
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000858
• Device Lot Number: 3847388
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2018
• 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: 69 YR
• Patient Weight: 116