MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM D; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Swelling (2091)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdrs were submitted for this event.Please see reports: 0001825034 - 2017 - 09672.0001825034 - 2017 - 09673.0001825034 - 2017 - 09674.Concomitant products: 010000702 g7 bonemaster ltd acet shl 50d lot 3899553.010000934 g7 hi-wall e1 liner 36mm d lot 3917173.51-199333 sirius hip stem 34-b lot 272940.51-199301 sirius wingless centralizer lot unk.650-0661 delta ceramic fem hd 36/0mm m t1 lot 2016101786.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported in the study the patient experienced lateral pain and tenderness upon palpatation of the left hip due to bursitis.The study reported no surgical intervention was necessary as it was treated with medication.The event was found to not be procedure or device related.The event was reported easily tolerated by patient, causing minimal discomfort and not interfering with everyday activities.The surgeon injected the patient with kenalog and lidocaine.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.Further investigation has determined that this device is unrelated to the event.

• Brand Name: G7 HI-WALL E1 LINER 36MM D
• 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: 6991260
• MDR Text Key: 90702554
• Report Number: 0001825034-2017-09672
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 010000934
• Device Lot Number: 3917173
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 10/31/2017
• Supplement Dates Manufacturer Received: 11/22/2017
• Supplement Dates FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 83