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
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field safety notice and capa was initiated as corrective action.
Event or Problem 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 or Problem 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].
Additional 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
• Common Device Name: 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
• Report Number: 3004371426-2024-00015
• Device Sequence Number: 7834666
• Product Code: JDG
• UDI-Device Identifier: 04026575024315
• UDI-Public: 04026575024315
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K953653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 03/22/2024
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown