MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

I was reported approximately 2 months ago in a primary surgery that the implants would not assemble correctly.When the surgeon inserted the inner part of the bipolar into the outer part, it was difficult to get in and the head inside was difficult to turn when pushed in.The surgeon used another size to complete the surgery.Diligence is complete and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).D10.Ringloc bipolar vit e 28x50mm, item#30302850, lot#65754434.G2.Report source: japan.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported in a primary surgery that the implants would not assemble correctly.When the surgeon inserted the inner part of the bipolar into the outer part, it was difficult to get in and the head inside was difficult to turn when pushed in.The surgeon used another size to complete the surgery.Diligence is complete and no further information on the reported event has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, b5, g3, g6, h2, h3, h6, h11.Product was returned and evaluated.Upon visual inspection the head does not move inside of the liner.There is a separation between the shell and the liner with the liner not aligned.Ceramtec reviewed the dimensional protocols of the item involved in this event.The measurement results show that the dimensions were within the specified tolerance.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre­ existing material defect.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were not provided.With the available information, a definitive root cause could not be determined.Upon reassessment of the event, it was found that this event was reported in error and should be voided.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: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18778738
• MDR Text Key: 337424851
• Report Number: 0009613350-2024-00059
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877502802
• Device Lot Number: 3168182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1