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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Claudication (2550)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).Concomitant medical products: echo bi-metric hip system catalog#192010 lot# 071360, biolox delta ceramic liner catalog# 110003619 lot# 3230050, delta ceramic femoral head catalog# 650-1162 lot# 2015011164.Report source: foreign: the event occurred in (b)(6).The device was not returned for evaluation due to unknown location.Review of the device history record (dhr) found one deviations or anomalies and concessions were noted.Review of complaint history for same or similar issue identified 18 additional complaints for part (item) number and no additional complaints were identified for part/lot combination.Without the opportunity to evaluate the device, the complaint was not confirmed and root cause could not be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Associated risk table lists "miscellaneous user needs (general post-operative pain )¿.Following review, no new risks were identified.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01237.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported as part of a clinical study that a patient underwent a right hip procedure (b)(6) 2016.Subsequently, the patient reported moderate pain, problems walking and moderate limp with no support required during one (1) year post operative follow up visit.Additionally, the patient's satisfactory rating decreased three (3) months to one (1) year post operatively.Attempts have been made and no further information has been provided.

• Brand Name: G7 ACETABULAR SHELL
• 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: 7288867
• MDR Text Key: 100693754
• Report Number: 0001825034-2018-01238
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: Physician
• 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: 02/22/2018
• 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: 010000664
• Device Lot Number: 3671981
• Other Device ID Number: (01) 0 0880304 524231 1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• 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: 60 YR
• Patient Weight: 73