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

Model Number N/A

Device Problems Material Deformation (2976); Difficult or Delayed Separation (4044)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (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 the threads stripped on the g7 pps ltd acet shell 50d during the operation.After the surgeon had inserted the shell into acetabulum, he tried to remove the inserter.But couldn't separate the inserter from the shell, so he removed the shell and inserter together with other instruments.Then he separated the inserter from shell successfully in vitro and found the thread stripped and the metal chips had fallen off, doctor use 54 d shell complete the operation.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.The following sections were updated/corrected updated: d4; d9; g3; h2; h3; h4; h6.  one g7 pps ltd acet shell 50d was returned and evaluated.Upon visual inspection the hex plugs have some scuffing visible but were able to be removed with the use of an allen wrench.When the porous coating is brushed some specks of the porous falls off no photos were taken of the specks as they were difficult to see.The threads of the apical hole are chipped.Dark debris is present within the apical plug.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.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.  multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02305.

• Brand Name: G7 PPS LTD ACET SHELL 50D
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11307591
• MDR Text Key: 232199528
• Report Number: 0001825034-2021-00433
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524217
• UDI-Public: (01)00880304524217(17)281012(10)6395500
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• 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: 6395500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 47 YR