MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACTABULAR SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 010000858 ¿ g7 neutral e1 liner ¿ 3862081; 650-1057 ¿ biolox delta ceramic head option ¿ 084170; therapy date: (b)(6) 2017.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 - 07221, 0001825034 - 2018 - 07223.

Event Description

It was reported patient underwent right revision approximately 2 months post implantation due to aseptic loosening of the acetabular component which had fallen into the cystic lesion.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.(b)(4).Reported event was confirmed by review of x-ray and medical records.Device was not returned.Review of the device history record (dhr) found no deviations or anomalies related to the reported event.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 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 ACTABULAR SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7764419
• MDR Text Key: 116535446
• Report Number: 0001825034-2018-07203
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000665
• Device Lot Number: 3896799
• 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: 56 YR
• Patient Weight: 94