MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 28MM A; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Subluxation (4525)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown month and day in 1953.Concomitant medical devices: catalog#: 110017328 g7 bispherical shell 44a lot#: 334515; catalog#: 650-0831 delta cer fm hd 028/0mm 12/14 lot#: 2018112087; catalog#: ps129gm4 gts standard fmrl stem size -4 lot#: 0001157625.Foreign country: (b)(6).The device will not be returned for analysis, due to the device being discarded; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a revision procedure approximately 3.5 months post implantation due to subluxation with flexion above 130 was reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d4, g3, g6, h2, h3, h4, h6, h10 the event was confirmed with medical records received.Review of the available records identified the following: initial surgery reviewed and no deviations or anomalies were identified.Medical records were reviewed and identified multiple subluxations in maximum flexion position of the right hip joint.Fibrosed, scarred capsule removed.Head and cup removed.Cup 48mm placed, screw fixation not required.Crf shows subluxation at 130 degrees.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

Event Description

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

• Brand Name: G7 NEUTRAL E1 LINER 28MM A
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11339625
• MDR Text Key: 232341498
• Report Number: 0001825034-2021-00520
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000835
• Device Lot Number: 3411930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2021
• 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: 65 YR
• Patient Weight: 44