MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG STANDARD PROSTHESIS HEADS, CERAMIC PROSTHESIS HEAD A, BIOLOX®; LINK PROSTHESIS HEAD A CERAMIC

Model Number 128-936/02

Device Problem Fracture (1260)

Patient Problem Hip Fracture (2349)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

The quality documents are reviewed.Further documents and the complaint sample were made available for an investigation.The incident will be investigated in cooperation with oem (ceramtec).After re-evaluation of the complaint we determined that this case is reportable as a foreign event.

Event Description

Translation: ceramic head defective.For revision surgery (b)(6) 2017 with lying cup and ceramic inlay (third-party product) and hip stem.Indication: periprosthetic fracture, hip shaft changed to mp with ceramic head telephone info on (b)(6) 2019 that ceramic is probably defective.New restoration inlay, neck section, intermediate ring, screw and ceramic head on (b)(6) 2019.

Manufacturer Narrative

[translate].The production documents and the acceptance test certificate have been inspected and checked by ceramtec.All test characteristics of this product correspond to the specifications valid at the time of manufacture.The density was determined on the existing fragments of the head and insert.The material-specific characteristics correspond to the respective specifications.There are no indications of a material defect.Secondary metal transfer can be found on both components, resulting from contact with metal parts after the primary damage event.Primary metal transfer is not present in the cone of the ceramic ball head.This indicates a disturbance of the interface between metal shaft and ceramic ball.Both primary fracture surfaces of the ball head can be identified.Due to secondary damage, the area of fracture formation cannot be identified.Furthermore, a primary metal transfer on the cone of the insert is not uniformly present, which indicates a disturbance of the interface between metal shell and insert.Here, too, the area of fracture origin cannot be determined unambiguously due to secondary damage.The cone surface of the neck part shows scratches as well as signs of wear, which indicate repeated contact with the insert and/or the fragments of the ball head after the fracture event.A failure of the interface between the metal shell and the ceramic insert may affect the stress distribution in the ceramic component and eventually cause fracture.Disruption of the interface between the metal shaft and the ceramic ball can lead to stress increases in the ball head and increase the risk of breakage.The fragments submitted for analysis do not allow a clear statement to be made as to which component is initially broken.The ceramic insert is from another manufacturer.According to the instructions for use, the combination with implants from other manufacturers and / or combinations of link implants that deviate from the specifications in the surgical technique is not verified by tests and is not permitted.

Event Description

Translation: ceramic head defective.For revision surgery on (b)(6) 2017 with lying cup and ceramic inlay (third-party product) and hip stem.Indication: periprosthetic fracture, hip shaft changed to mp with ceramic head telephone info on (b)(6) 2019 that ceramic is probably defective new restoration inlay, neck section, intermediate ring, screw and ceramic head on (b)(6) 2019.

• Brand Name: STANDARD PROSTHESIS HEADS, CERAMIC PROSTHESIS HEAD A, BIOLOX®
• Type of Device: LINK PROSTHESIS HEAD A CERAMIC
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8463669
• MDR Text Key: 140278835
• Report Number: 3004371426-2019-00118
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: K953653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 128-936/02
• Device Catalogue Number: 128-936/02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 85