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

Catalog Number 010000858

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Host-Tissue Reaction (1297); Hematoma (1884); Joint Dislocation (2374)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Dhr reviewed.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Udi# (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04848.

Event Description

It was reported that a patient underwent a left total hip arthroplasty.Patient suffered 2 dislocations and underwent a revision approximately 3 weeks later.The liner, head, and stem were removed and replaced.A pseudocapsule was noted and removed.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Reported event was confirmed with medical records/radiographs provided.Review of the available records identified the following: revision of head, liner, and stem due to instability.Hematoma encountered consistent with previous surgery and dislocations, unable to recreate instability.Pseudocapsule noted and removed.Review of the device history records identified no deviations or anomalies during manufacturing.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 36MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9239387
• MDR Text Key: 163807576
• Report Number: 0001825034-2019-04805
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2024
• Device Catalogue Number: 010000858
• Device Lot Number: 6455464
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOLOXA HEAD CAT#00877503602 LOT#2990965; G7 ACET SHELL CAT#010000665 LOT#6483998; STEM 12/14 NECK TAPER CAT#00771101000 LOT#64145131; BIOLOXA HEAD CAT#00877503602 LOT#2990965; G7 ACET SHELL CAT#010000665 LOT#6483998; STEM 12/14 NECK TAPER CAT#00771101000 LOT#64145131
• Patient Outcome(s): Hospitalization; Required Intervention