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

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded by the hospital.Concomitant medical products: item number: 010000861, item name: g7 e1 neutral liner, lot #: 6260948.Item number: unknown, item name: unknown head, lot #: unknown.Item number: unknown, item name: unknown stem, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03870.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial hip arthroplasty the liner would not completely seat into the shell.Another liner was used to complete the case.No adverse impact to patient was reported.No additional information is available at this time.

Manufacturer Narrative

Upon reassessment of the reported event, the cup was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, the cup was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN G7 SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8949242
• MDR Text Key: 156092144
• Report Number: 0001825034-2019-03871
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1