MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 56F; PROSTHESIS - HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 08/24/2016

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01227, 0001825034-2018-01228, 0001825034-2018-01230.Concomitant products: cat 192115 ¿ lot 182440 - echo por fmrl lat nc, cat 163672 ¿ lot 00j3208701 ¿ 32mm mod head cocr +9mm neck, cat 010000850 ¿ lot 3575908 - g7 neutral e1 liner.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.The device history records and found no deviations related to this complaint.This device is used for treatment.The reported components were reviewed for compatibility with no issues noted.No medical records received.Root cause could not be determined with information available.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.This report is being submitted late as it has been identified in remediation.

Event Description

Clinical study (b)(6) patient underwent a left tha on (b)(6) 2016.On 3 month eq5d form, they reported having some problems walking about, washing/ dressing themselves, performing usual activities and moderate pain or discomfort.On one year eq5d form, they reported having some problems walking about, washing/ dressing themselves, performing usual activities and reported extreme pain and discomfort.Pain/satisfaction rating was 8 at the 1-year followup visit.On (b)(6) 2018 - per review by clinician on (b)(6) 2018, moderate pain and difficulty with adls at 3mo is not an abnormal finding.Preop patient rates pain numerically as 10/10 at rest and 8/10 when moving.At 3mo patient reports zero pain with rest and 3 when moving with a satisfaction score of 10/10-very satisfied.Preop harris reports pain as totally disabling, crippling, bed ridden, severe limp, 2 crutches or walker, indoor walking only, unable to use public transportation.At 3mo mild pain, no effect on average activity, no limp, no longer using assistive devices, able to walk 6 blocks.By one year harris patient reports no pain, no use of assistive devices, slight limp, with a continues satisfaction score of 10/10-very satisfied.At one year pain at rest and when moving have increased to 5 and 8 respectively and eq5d reports extreme pain, even though oxford and harris scores both report none or no pain related to the hip and a 10/10-very satisfied sore.Contributing factors are osteoarthritis of right hip, right knee, left knee, and ankles, as well as unknown malignancy and endocrine disease.Extreme pain, 8/10, at one year postop is a complaint.

• Brand Name: G7 PPS LTD ACET SHELL 56F
• 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: 7287742
• MDR Text Key: 100646085
• Report Number: 0001825034-2018-01229
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000665
• Device Lot Number: 3568094
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2015
• 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): Other
• Patient Age: 50 YR
• Patient Weight: 106