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

Model Number 127-728/26

Device Problem Unclear Information (4052)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

A field safety notice and capa was initiated as corrective action.

Event Description

"customer performed surgery according to surgical technique.Trial reduction was done with 126 xl neck segment, which was then selected for definitive implant (r4 w/ xl neck).When circulating nurse showed the implant label to surgeon before opening the package, the size marking on the label ("x-large r4") was misinterpreted as "xl-neck r4".Stem was then implanted and it was noticed only after the cement was cured that it had standard neck but not xl." [customer].

Event Description

"customer performed surgery according to surgical technique.Trial reduction was done with 126 xl neck segment, which was then selected for definitive implant (r4 w/ xl neck).When circulating nurse showed the implant label to surgeon before opening the package, the size marking on the label ("x-large r4") was misinterpreted as "xl-neck r4".Stem was then implanted and it was noticed only after the cement was cured that it had standard neck but not xl." [customer].

Manufacturer Narrative

A field safety notice and capa was initiated as corrective action.This is the final supplemental report, the complaint is closed.

• Brand Name: SPII MODEL LUBINUS
• Type of Device: LUBINUS SPII HIPPROSTH. STEM,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: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 18639792
• MDR Text Key: 334534820
• Report Number: 3004371426-2024-00015
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 04026575024315
• UDI-Public: 04026575024315
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 127-728/26
• Device Catalogue Number: 127-728/26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 03/22/2024
• Date Device Manufactured: 05/01/2023
• 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