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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Blood Loss (2597)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and 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: 0001825034-2019-00773; 0001825034-2019-00775; 001825034-2019-00776.

Event Description

It was reported that during a hip revision surgery the liners would not lock into the cup causing additional blood loss.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The examination of the returned device shows no visible damage to the outer diameter but does show impaction to the scallops.Review of the device history record(s) identified no related deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: blood loss 1400 ml.3 u prbc¿s transfused.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.

• 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: 8358285
• MDR Text Key: 136760928
• Report Number: 0001825034-2019-00774
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000870
• Device Lot Number: 6152443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 110010270 G7 OSSETOTI MULTIHOLE, 6298126; 110017230 G7 NEUTRAL E1 LINER 3735600; 110017231 G7 NEUTRAL E1 LINER 6152443; 110010270 G7 OSSETOTI MULTIHOLE, 6298126; 110017230 G7 NEUTRAL E1 LINER 3735600; 110017231 G7 NEUTRAL E1 LINER 6152443
• Patient Outcome(s): Hospitalization; Required Intervention