MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG ARCOMXL LINER 36MM F; HIP PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical products: item # 11-363661, head, lot # 439230, item # 51-103150, stem, lot # 3899138, item # 01000664, shell, lot # 6028983.Multiple reports are being submitted for this even.Please see associated reports: 0001825034-2018-04459, 0001825034-2018-04466, 0001825034-2018-04467.

Event Description

It was reported that a patient has been experiencing pain for approximately 1 year post implantation.Tested negative for infection.Lab work for metal allergy being discussed.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 further event information available at the time of this report.

• Brand Name: G7 10 DEG ARCOMXL LINER 36MM F
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7775032
• MDR Text Key: 116856759
• Report Number: 0001825034-2018-04464
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000780
• Device Lot Number: 6014189
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 70