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 Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 03/19/2024

Event Type  malfunction  

Event Description

It was reported in a primary hip surgery the ceramic head was chipped fractured/chipped during impaction.There was no impact to patient and the surgery was completed with another head.Diligence is completed and additional information is unavailable at this time.

Manufacturer Narrative

(b)(4).D10.G7 dual mobility liner 42mm e item# 110024463 lot# 66468245.G7 osseoti 3 hole shell 52mm e item# 110010244 lot# 66283179.Avenir cmpl ha ho nc size 4 item# 574102040 lot# 3176270.Vivacit-e dm bearing 28x42mm item# 110031011 lot# 66326537 biolox delta fem head, 28mm, +0mm item# 00-8775-028-02 lot# 3170540 28mm i.D.42mm o.D.Size e bearing item# 110031011 lot# 66326537 28mm i.D.42mm o.D.Size e bearing item# 110031011 lot# 66433257 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.

• 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: 19088892
• MDR Text Key: 340622169
• Report Number: 0009613350-2024-00134
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430297
• UDI-Public: (01)00889024430297(17)330918(10)3175527
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00877502802
• Device Lot Number: 3175527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11 NARRATIVE.