MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 56F; PROSTHETIC, HIP

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis per hospital policy; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01449.

Event Description

It was reported during a initial hip procedure that the g7 shell was attached to the g7 inserter to be implanted into the patient, but became cold welded to the g7 inserter and was unable to be removed.Procedure completed with second implant.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. visual examination of the provided pictures identified the cup and inserter were detached from one another.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.Medical records were not provided.A definitive root cause cannot be determined, however it was noted upon removal of the shell from the inserter with a pair of pliers the devices appeared to be cross threaded.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.

• Brand Name: G7 PPS LTD ACET SHELL 56F
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11825549
• MDR Text Key: 250665498
• Report Number: 0001825034-2021-01447
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524248
• UDI-Public: (01)00880304524248(17)301104(10)6893541
• 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: 09/02/2021

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: 010000665
• Device Lot Number: 6893541
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1