MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACETABULAR SHL 60G; PROSTHESIS, HIP

Model Number N/A

Device Problems Flaked (1246); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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.

Event Description

It was reported that there was difficulty inserting the shell.After several attempts, it was noticed that some of the plasma coating was coming off on the shell.No adverse events have bee reported as a result of this malfunction.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by inspection of device.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A g7 pps ltd acetabular shl 60g, part # 010000667 from lot 6578906, was returned and evaluated against the complaint.Visual inspection found blue and yellow debris within the porous coating, however, this is likely to be due to the return packaging material as they are visually consistent.The graticule check was performed.A 5x magnification was used.The porous coat area sits between the tolerance bands when lined up with the shell profile, as required.The brush test was performed and the result was found to be out of specification.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 PPS LTD ACETABULAR SHL 60G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9918118
• MDR Text Key: 188870653
• Report Number: 0001825034-2020-01454
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000667
• Device Lot Number: 6578906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1