MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 4 HOLE SHELL 54MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Source: (b)(6).Concomitant medical products: catalog number: 110003450 lot number:774160 brand name: g7 str shell insrtr.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00091.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 during an initial hip arthroplasty, the inserter would not disengage from the shell after impaction.No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable.

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.A g7 shell and an inserter were returned and evaluated against the complaint.The inserter and shell remain seized together upon receipt.The devices could not be disassembled by hand and the threads could not be observed.No signs of debris or cross-threading were seen.The inserter handle is discolored.Scratches are present on the inner radius of the shell.Foreign debris is stuck within the porous coating of the shell.Complaint sample was evaluated and the reported event was confirmed.Device history record was reviewed and no discrepancies were found.Root cause could not 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.

• Brand Name: G7 OSSEOTI 4 HOLE SHELL 54MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11195144
• MDR Text Key: 227575358
• Report Number: 0001825034-2021-00090
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K140669
• 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: 04/13/2021

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: 110010245
• Device Lot Number: 6815878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1