MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA CERAMIC TAPER LINER, SIZE EE / 28 I.D; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2.Report source: china.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 approximately 1 month ago a hip replacement was performed following the surgical procedure, the acetabular cup and stem were fitted, the liner was placed, and the ceramic liner was found to be broken during repositioning.All pieces were removed after cleaning.No impact to patient.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.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

Diligence is completed 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.The following sections were updated: the biolox delta taper liner was returned for examination.A piece of the rim is broken off.The edge around the chipped piece shows slight traces of metal.A trace of metal can also be seen on the fracture surface itself.These metal traces along the broken edge and on the fracture surface point to contact with a metal component.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.A total of 3 intraoperative photographs were received.One photograph shows the surgical site with a partial view of the seated cup with the liner in place with a fractured fragment of the rim with ceramic chips.The surface of the cup next to the fracture site appears polished which points to contact with a metal component.The second photograph shows the removed liner with ceramic chips and traces of metal at the fracture site.The third photograph shows the opened product packaging.Based on the visual examination of the returned liner and the photographs provided, it is possible that the piece of the rim broke off due to the impact of a metal component.Nonetheless, the definitive cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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

Diligence is completed and additional information on the reported event is unavailable at this time.

• Brand Name: BIOLOX® DELTA CERAMIC TAPER LINER, SIZE EE / 28 I.D
• 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: 18416714
• MDR Text Key: 331600900
• Report Number: 0009613350-2023-00723
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 02/23/2024

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: 00877500628
• Device Lot Number: 3143703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/10/2024; 02/16/2024
• Supplement Dates FDA Received: 02/08/2024; 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• 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
• Patient Age: 29 YR