MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 POROUS PLASMA SPRAY LIMITED ACETABULAR SHELL 50D; HIP PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to implants being discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source, foreign - event occurred in (b)(6).Medical devices: 010000982, g7 freedom const e1 lnr 36mm d, 3791913, 00811400100, femoral stem 12/14 neck taper standard offset size 1 130 mm stem length, 63277191, 14-107018, frdm cnstr hd 36mm t12/14 std, 833640.

Event Description

It was reported that patient underwent a hip revision surgery approximately 9 months post implantation due to a bone fracture from a fall.The cause of the fall is unknown at this time.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 POROUS PLASMA SPRAY LIMITED ACETABULAR SHELL 50D
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7603405
• MDR Text Key: 111139227
• Report Number: 0001825034-2018-04005
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 010000662
• Device Lot Number: 6096524
• Other Device ID Number: (01) 0 0880304 52421 7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention