MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 40MM F; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: 650-1058, ceramic bioloxd option head 40mm, 142370; 00700006020, trabecular metalâ¿¢ acetabular revision shell, 63526365.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 - 01844.Product location unknown.

Event Description

It was reported that the patient had a left revision procedure eight months post-implantation due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).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.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 additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient had a left revision procedure eight months post-implantation due to dislocation.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: G7 NEUTRAL E1 LINER 40MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7338947
• MDR Text Key: 102386144
• Report Number: 0001825034-2018-01845
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 010000864
• Device Lot Number: 3891468
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2018
• 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: 72 YR