MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FRDM CONST E1 10DEG LNR 32C; PROSTHESIS, HIP

Model Number N/A

Device Problems Disassembly (1168); Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 07/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000661, g7 pps ltd acet shell 48c, 3075270.The 110025132, freedom constr hd 32 mm t1 -3 mm, 368620.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: 0001825034-2017-11390.Remains implanted.

Event Description

It was reported that during a revision procedure the acetabular cup was fractured, and the locking ring had disassociated from the shell.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined that there was no alleged deficiency or event to be reported.The initial report was forwarded in error and should be voided.

• Brand Name: G7 FRDM CONST E1 10DEG LNR 32C
• Type of Device: PROSTHESIS, HIP
• 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: 7148393
• MDR Text Key: 95840437
• Report Number: 0001825034-2017-11391
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/02/2020
• Device Model Number: N/A
• Device Catalogue Number: 110010280
• Device Lot Number: 3579597
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2015
• 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
• Patient Age: 67 YR
• Patient Weight: 72