MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACETABULAR SHELL 50D; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000848, 6495774, g7, neutral, e1, liner, 32mm, d, 00625006530, 64339340, bone, scr, 6.5x30, self-tap, unknown, head, unknown, stem, report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.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 - 03767.

Event Description

It was reported during hip surgery, the liner would not seat into cup.A second liner was opened and used.No adverse events have been reported as a result of the malfunction.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.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified circular indentation on the outside diameter of the liner.A small nick was identified on the locking feature of the liner.The imprints on the outer radius were consistent with the size and shape of the screw head used in g7 implantation.Manufacturing records confirm that the dimensions where measured are found conforming to print specifications at the time of manufacturing.The device history record was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was attributed to the presence of screws impinging with the liner.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 SHELL 50D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8923861
• MDR Text Key: 201074846
• Report Number: 0001825034-2019-03769
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 010000662
• Device Lot Number: 6449985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1