MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 51-114140 taperloc femoral stem 6278701; 010000937 g7 acetabular liner, 6358739; 010000097, g7 locking screw, 6329794; 010000999, g7 screw, 6301015; 650-0662, delta ceramic head, 2016120783.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, hospital discarded the explants.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 - 11357 , 0001825034 - 2018 - 11359.

Event Description

It was reported that a patient underwent a hip arthroplasty revision due to acetabular loosening approximately 23 days post implantation.No additional patient consequences were reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies 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 report 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 PPS LTD ACET SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8171484
• MDR Text Key: 130611228
• Report Number: 0001825034-2018-11343
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000667
• Device Lot Number: 3124081
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2019
• 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