ECOFIT SHORT STEM STANDARD CEMENTLESS SZ. 11,25MM CPTI
Report
- Report Number
- 3012523063-2025-00087
- Event Type
- Malfunction
- Date Received
- October 15, 2025
- Date of Event
- September 12, 2025
- Report Date
- December 19, 2025
- Manufacturer
- IMPLANTCAST GMBH
- Product Code
- LZO
- PMA / PMN Number
- K163577
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "IT WAS PREPARED FOR A STEM SIZE OF 11.25 STD ECOFIT SHORT, AND THIS STEM WAS ALSO TAKEN FROM THE KONSI CABINET. HOWEVER, THE PACKAGE CONTAINED A DIFFERENT STEM (ECOFIT SHORT SIZE 10 LATERALISED). REF 30420100, LOT 1746299007 - IS BARELY LEGIBLE..." NEITHER THE AFFECTED PRODUCT NOR ITS COUNTERPART ARE CURRENTLY AVAILABLE FOR VISUAL INSPECTION. HOWEVER, PHOTOGRAPHS OF THE COUNTERPART HAVE BEEN PROVIDED. THE PHOTOGRAPHS SHOWED THAT THE ARTICLE NUMBER AND THE LOT NUMBER OF THE ENGRAVING ON THE STEM DO NOT MATCH THE LABEL ON THE INNER AND OUTER PACKAGING AS REPORTED TO IMPLANTCAST. BOTH PRODUCTS WERE LOCATED AND SECURED SO THAT THEY COULD NO LONGER BE USED. A CORRECTIVE-ACTION-REPORT HAS BEEN INITIATED TO DETERMINE THE CAUSE AND DEFINE MEASURES. NO RESULTS ARE CURRENTLY AVAILABLE. THE INCIDENT WAS ASSIGNED TO THE HAZARD "INSUFFICIENT LABELING" IN THE ASSOCIATED RISK MANAGEMENT.
THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "IT WAS PREPARED FOR A STEM SIZE OF 11.25 STD ECOFIT SHORT, AND THIS STEM WAS ALSO TAKEN FROM THE KONSI CABINET. HOWEVER, THE PACKAGE CONTAINED A DIFFERENT STEM (ECOFIT SHORT SIZE 10 LATERALISED). REF 30420100, LOT 1746299007 - IS BARELY LEGIBLE...". THE AFFECTED PRODUCT AND ITS COUNTERPART WERE LOCATED AND SECURED SO THAT THEY COULD NO LONGER BE USED. THE OPTICAL EXAMINATION SHOWED A CORRECT ENGRAVING ON THE STEMS, BUT THERE ARE DISCREPANCIES ON ALL LABELS SHOWING THE PRODUCT DATA OF THE COUNTERPART INVOLVED. FURTHERMORE, THE MANUFACTURING DOCUMENTS WERE FREE OF ERRORS. HOWEVER, THE INVESTIGATION REVEALED THAT A MIX-UP OCCURRED INTERNALLY DURING THE RESTERILIZATION PROCESS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED MIX-UP OCCURRED WITHIN THE MANUFACTURING PROCESS OF THE AFFECTED PRODUCTS. THE LABELS AND PACKAGED PRODUCTS WERE MISTAKENLY SWITCHED DURING THE REPACKAGING DUE TO AN ISOLATED CASE OF HUMAN ERROR. THE OPERATION TIME WAS PROLONGED BY 5 MINUTES. THE OPERATION COULD BE COMPLETED SUCCESSFULLY AS A SECOND ECOFIT® SHORT STEM STANDARD CEMENTLESS SIZE 11.25 MM CPTI WAS AVAILABLE. THERE ARE CURRENTLY NO POSTOPERATIVE CONSEQUENCES FOR THE PATIENT KNOWN. THE INCIDENT WAS ASSIGNED TO THE HAZARD "INSUFFICIENT LABELING" IN THE ASSOCIATED RISK MANAGEMENT. THE OCCURRENCE RATE IS BELOW THE SPECIFIED LIMIT VALUE.
THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "IT WAS PREPARED FOR A STEM SIZE OF 11.25 STD ECOFIT SHORT, AND THIS STEM WAS ALSO TAKEN FROM THE KONSI CABINET. HOWEVER, THE PACKAGE CONTAINED A DIFFERENT STEM (ECOFIT SHORT SIZE 10 LATERALISED). REF 30420100, LOT 1746299007 - IS BARELY LEGIBLE..." NOTE FROM IMPLANTCAST: THE COUNTERPART WAS ALSO IDENTIFIED AND SECURED.
THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "IT WAS PREPARED FOR A STEM SIZE OF 11.25 STD ECOFIT SHORT, AND THIS STEM WAS ALSO TAKEN FROM THE KONSI CABINET. HOWEVER, THE PACKAGE CONTAINED A DIFFERENT STEM (ECOFIT SHORT SIZE 10 LATERALISED). REF 30420100, LOT 1746299007 - IS BARELY LEGIBLE..." NOTE FROM IMPLANTCAST: THE COUNTERPART WAS ALSO IDENTIFIED AND SECURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1994182 | ECOFIT SHORT STEM STANDARD CEMENTLESS SZ. 11,25MM CPTI | STEM | LZO | IMPLANTCAST GMBH | 30321125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R | ECOFIT® SHORT STEM LATERALIZED CEMENTLESS SZ. 10MM |