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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05154.

Event Description

During an initial surgery it was reported that a surgeon attempted to implant the liner, it would not seat at all.There were 2-3 rotation tabs that were sitting proud and not fully seating in the cup.Several attempts were made to get the liner fully seated, but surgeon was unable to do so.Once the original liner was removed, surgeon re-checked the screws to make sure they were seated, he did not see anything that would have caused the liner to not seat.A new liner was used to complete the procedure.Attempts were made to obtain additional information; however, none was available.

Event Description

Upon further investigation, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon further investigation, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: G7 PPS LTD ACET SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9327744
• MDR Text Key: 201850791
• Report Number: 0001825034-2019-05158
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• 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: 010000668
• Device Lot Number: 6413720
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: G7 HI-WALL E1 LINER 36MM H, 010000938, LN 6177109.