MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 52E; PROSTHESIS HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.(b)(4).Concomitant medical products: item number: 11-107017, item name: freedom constr hd 36mm t1 -3mm, lot number: 295100; item number: 010000983, item name: g7 freedom const e1 lnr 36mm e, lot number: 3217325; item number: ni, item name: unknown femoral stem, lot number: ni; item# 010000998 g7 screw 6.5mm x 25mm lot# 3085124; item#103203  taperloc por fmrl 9x137 lot# 005300.  reported event was confirmed by review of radiographs.X-rays were provided and the review identified screw was fractured laterally.Lucency surrounding the superior and superolateral aspect of the acetabular cup suggesting loosening.The cup was horizontally oriented.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2018 -09004 - 3.

Event Description

It was reported the patient underwent a hip arthroplasty revision due to a fractured screw, pain, and an acetabular defect.A custom triflange was implanted.Attempts were made to obtain additional information; however, none was available.

• Brand Name: G7 PPS LTD ACET SHELL 52E
• 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: 8356445
• MDR Text Key: 136723517
• Report Number: 0001825034-2019-00416
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000663
• Device Lot Number: 3087066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2013
• 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: 46 YR
• Patient Weight: 58