MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG SPII MODEL LUBINUS; LUBINUS SPII HIPP. STEM XL, 150 MM,X-LARGE, R., COCRMO,TAPER 12/14, 126°CCD

Model Number 127-768/26

Device Problem Unclear Information (4052)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2022

Event Type  Injury  

Event Description

"hip replacement surgery.The dr.Chooses size 4 of the spii stem.The stem is firmly cemented.Then the doctor noticed that they have implanted a prosthesis size 4(xl) with xl neck version instead of a size 4(xl) with the standard neck version.They are forced to remove the stem and cement.The additonal hardened cement are removed with ultrasonic technology to be able to get a stem down to the right size." [customer].

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.A field safety notice and capa was initiated as corrective action.Foreign event subsequent reporting due to fsn r-2024-03.

• Brand Name: SPII MODEL LUBINUS
• Type of Device: LUBINUS SPII HIPP. STEM XL, 150 MM,X-LARGE, R., COCRMO,TAPER 12/14, 126°CCD
• 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: 18659133
• MDR Text Key: 334755769
• Report Number: 3004371426-2024-00018
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2022

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 Model Number: 127-768/26
• Device Catalogue Number: 127-768/26
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention