MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL 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); Neck Stiffness (2434)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000662-g7 pps ltd acet shell 50d-6149828, 193108- echo b-mtrc mp fp ho 8-66931or, 650-1057-cer bioloxd option hd 36mm-2904536.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01498, 0001825034-2020-01503.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient is experiencing increased pain 2 years post implantation.A bone scan was performed and mri planned.No further intervention has been reported at this time.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed.Medical and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: follow up visit for left hip pain described as dull soreness and stiffness to the left hip that is worse after sitting in the same position for a long time, with heaviness.Previous treatment did help.Also states pain increases with activity.Assessment appears to be within normal limits as well as x-rays.Plan to rule out infection with blood testing.Two year follow up visit patient continues to have to have dull soreness and stiffness to left hip worse after sitting in same position for a long time but improved over last time.X-rays continue to show well positioned implants.No treatment ordered.One year later ongoing symptoms with left hip.Assessment continues to be within normal limits as well as imaging.Orders noted for l-spine mri evaluation for l3-l4 spinal stenosis.Review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event for items 010000856 and 010000662.A definitive root cause cannot be determined.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.

Event Description

No additional information on reported event.

• Brand Name: G7 NEUTRAL E1 LINER 36MM D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9938394
• MDR Text Key: 190020150
• Report Number: 0001825034-2020-01501
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000856
• Device Lot Number: 6025178
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 56