MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA CERAMIC TAPER LINER, SIZE II / 36 I.D; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) g2.Report source: india.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported in a primary hip replacement case the liner was unable to fix in the cup adequately, was identified there might be some defect in the liner immediately surgeon used another ceramic liner and completed the surgery.No consequences or impact to the patient.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: b4, d9, g3, g6, h2, h3, h6, h11.The insert was returned for investigation.The rim and the articulation surface are inconspicuous.On the backside, it is possible to see a series of scratches and metal transfer.Commonly observed metal transfers from the seating are also visible all around the taper region.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.Review of the manufacturing records confirm that the insert was manufactured according to specification; therefore, it is not expected that the manufacturing process contributed to the reported issue.As the shell involved in the reported event was not returned, a product evaluation on this item could not be performed and an assembly test could not be carried out.Based on the available information, a definitive root cause for the reported event could not be established.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 TAPER LINER, SIZE II / 36 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: 18825685
• MDR Text Key: 336768417
• Report Number: 0009613350-2024-00077
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024429901
• UDI-Public: (01)00889024429901(17)330614(10)3162379
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 05/16/2024

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: 00877501036
• Device Lot Number: 3162379
• 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: 02/06/2023
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• 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: 40 YR
• Patient Sex: Male