MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN G7 CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:010000846 lot number: 6598585 brand name: g7 neutral e1 liner 32mm.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00247.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returne for evaluation.

Event Description

It was reported that during an initial hip arthroplasty , the liner would not seat into the cup.Both liner and cup were removed.No additional information is available.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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: UNKNOWN G7 CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9592162
• MDR Text Key: 175078279
• Report Number: 0001825034-2020-00248
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/24/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 04/15/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other