FDA Adverse Event
Other
Summary report: N
METASUL LARGE DIAMETER HEAD 54/T
MDR report key: 927846
·
Received October 16, 2007
Report
- Report Number
- 9613350-2007-00057
- Event Type
- Other
- Date Received
- October 16, 2007
- Date of Event
- October 1, 2007
- Report Date
- October 16, 2007
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANOTHER COUNTRY MFR HAS BLOCKED THE AFFECTED LOTS AND INITIATED A RECALL, PIECES WERE DELIVERED TO USA. NO DELAY OF SURGERY WAS REPORTED OF INCIDENT IN TO ANOTHER COUNTRY. CORRECT STICKER WAS PRINTED AND SENT TO HOSPITAL FOR THE PATIENT DOCUMENTS.
Description of Event or Problem · 1
IT IS REPORTED THAT HOSPITAL OPENED THE DEVICE WHICH WAS CORRECT BUT THE PATIENT LABELS STATE A PRODUCT CODE OF A LOR SHELL, LOT. 2368322. PRODUCT INSIDE CORRESPONDS WITH PACKAGING, ONLY PATIENT LABELS ARE INCORRECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | METASUL LARGE DIAMETER HEAD 54/T | TOTAL HIP PROSTHESIS | KWA | ZIMMER GMBH | NA | 2378396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |