MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG SPII MODEL LUBINUS HIP STEM; SPII MODEL LUBINUS HIP PROSTHESIS STEM, ENDODUR (COCRMO ALLOY), TAPER 12/14 MM,

Model Number 127-720/35

Device Problems Fracture (1260); Off-Label Use (1494); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 07/21/2023

Event Type  Injury  

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.This is the final supplemental report, the complaint is closed.

Event Description

Broken hip stem.

• Brand Name: SPII MODEL LUBINUS HIP STEM
• Type of Device: SPII MODEL LUBINUS HIP PROSTHESIS STEM, ENDODUR (COCRMO ALLOY), TAPER 12/14 MM,
• 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: 17486008
• MDR Text Key: 320663318
• Report Number: 3004371426-2023-00076
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 04026575225439
• UDI-Public: 04026575225439
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/25/2023

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: 11/30/2022
• Device Model Number: 127-720/35
• Device Catalogue Number: 127-720/35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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: 70 YR
• Patient Sex: Female