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

Model Number 127-721/26

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

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 06/02/2021

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

Prosthesis stem fracture.

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

Prosthesis stem fracture.

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

Prosthesis stem fracture.

• Brand Name: LUBINUS SPII HIP
• Type of Device: PROSTH. STEM,150 MM, X-NARROW, L.,COCRMO, TAPER 12/14, 126°CCD
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 13059729
• MDR Text Key: 285357003
• Report Number: 3004371426-2021-00038
• Device Sequence Number: 1
• Product Code: JDG
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 127-721/26
• Device Catalogue Number: 127-721/26
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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: 52 YR
• Patient Sex: Female