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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Pain (1994); Blood Loss (2597); No Information (3190)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Udi: (b)(4).Concomitant medical products: item number: xl-200150, item name: active articulation head, lot #: 981030; item number: 163666, item name: femoral head bearing, lot #: 553980; item number: 110017105, item name: g7 shell, lot #: 366265; item number: 51-107140, item name: taperloc stem, lot #: 3612807.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08165, 0001825034 - 2018 - 08166.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient was hospitalized approximately two weeks post-implantation due to excessive bleeding from the wound site.Attempts have been made and no additional information is available.

Event Description

It was reported that patient was hospitalized approximately 2 weeks post revision surgery due to excessive bleeding/delayed wound healing.The patient was taken into surgery the next day due to experiencing pain, and loosening.During the surgery, a mass filled with fluid was removed and a wound vac system was inserted.

Manufacturer Narrative

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 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01184, 0001825034 - 2019 - 01185.

• Brand Name: G7 LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7791172
• MDR Text Key: 117419253
• Report Number: 0001825034-2018-08164
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK150522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110024464
• Device Lot Number: 671750
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 93