MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LUBINUS SP II; SP II PROSTHESIS STEMS

Model Number 127-721/26

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

Patient Problem Failure of Implant (1924)

Event Date 04/17/2023

Event Type  Injury  

Event Description

Broken hip stem.

Event Description

Broken hip stem.

Manufacturer Narrative

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

• Brand Name: LUBINUS SP II
• Type of Device: SP II PROSTHESIS STEMS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16972107
• MDR Text Key: 315761678
• Report Number: 3004371426-2023-00026
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 04026575225507
• UDI-Public: 04026575225507
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K953653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

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: 12/31/2011
• Device Model Number: 127-721/26
• Device Catalogue Number: 127-721/26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 05/08/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2006
• 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: 87 YR
• Patient Sex: Male