MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LUBINUS SP II; LUBINUS SPII® HIP PROSTH. STEM,150 MM, X-NARROW, R.,COCRMO, TAPER 12/14, 126°CCD

Model Number 127-720/26

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

Event Description

Sp ii stem fracture (implanted in 2010).

Event Description

Sp ii stem fracture (implanted in 2010).

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.On the basis of the available information and surgical report, it can be assumed that an initial loosening of the stem with a fixed distal part in combination with high load from the patient, led to the fracture of the stem.The high offset from the xl prosthesis head in combination with extra narrow stem and under high load from patient creates a lever arm action with higher concentration of forces which could explain the initial loosening followed by the erratic course of the fracture.

• Brand Name: LUBINUS SP II
• Type of Device: LUBINUS SPII® HIP PROSTH. STEM,150 MM, X-NARROW, R.,COCRMO, TAPER 12/14, 126°CCD
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: sagar shetty ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 12850469
• MDR Text Key: 282549139
• Report Number: 3004371426-2021-00030
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: K953653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

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 Expiration Date: 12/31/2014
• Device Model Number: 127-720/26
• Device Catalogue Number: 127-720/26
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2009
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 110 KG