MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA CERAMIC TAPER LINER, SIZE GG / 32 I.D. WITH 48 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 03/28/2024

Event Type  malfunction  

Event Description

It was reported that during an initial surgery the ceramic liner was found to be broken after gently inserting the corresponding insertion tool.Subsequently, when preparing for the installation of the new ceramic liner, it was found that there was damage to the inner rim of the cup.All pieces were removed from the patient.Diligence is complete and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).D10.48mm o.D.Size gg porous uncemented with multi-holes shell use with gg liners item# 00875704802 lot# 66459626.G2.Report source: china.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 TAPER LINER, SIZE GG / 32 I.D. WITH 48 MM O.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: 19143759
• MDR Text Key: 341138114
• Report Number: 0009613350-2024-00145
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024429864
• UDI-Public: (01)00889024429864(17)320908(10)3127900
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/19/2024

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: 00877500832
• Device Lot Number: 3127900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2022
• 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.
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 53 KG