MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 52E; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00625006530-bone scr 6.5x30 self-tap-64676705.00625006530-bone scr 6.5x30 self-tap-64629272.010000857-g7 neutral e1 liner 36mm e-6623355.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 the patient¿s acetabular screw was found to have either pulled through the cup or was pushed through the cup post implantation via x-ray.No revision 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.Upon receipt of additional information, it has been determined there is no alleged event against the zimmer biomet shell additionally there were two screws utilized in which the second is correct which would lead the issue to either be the screw itself or technique in putting the screw in.Therefore, the initial report was submitted in error and should be voided.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

Upon receipt of additional information, it has been determined there is no alleged event against the zimmer biomet shell additionally there were two screws utilized in which the second is correct which would lead the issue to either be the screw itself or technique in putting the screw in.Therefore, the initial report was submitted in error and should be voided.

• Brand Name: G7 PPS LTD ACET SHELL 52E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10424655
• MDR Text Key: 203463162
• Report Number: 0001825034-2020-03199
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000663
• Device Lot Number: 6554683
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other