MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-02-01 for MOST OPTIONS HINGED TIBIA BASEPLATE 502000001 manufactured by Zimmer, Inc..
[786872]
It is reported that the surgery occurred in 2008. During surgery, the baseplate box was opened and a screw needed for the next step was missing. Another baseplate had to be located to replace the missing screw. During this delay, the bone cement had dried and had to be removed and fresh cement applied. Surgery was delayed for 2 hours.
Patient Sequence No: 1, Text Type: D, B5
[7952832]
Evaluation summary: cause cannot be definitively determined. Evaluation: manufacturing records indicate that the collet screw was packaged with device. The lot was manufactured and packaged in august 2007 and has been fully distributed. No other complaint reports have been received for the related manufactured lot. It is possible that the screw was discarded with the packaging during surgery but it can not be determined with certainty with the available information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2008-00036 |
| MDR Report Key | 990421 |
| Report Source | 05,07 |
| Date Received | 2008-02-01 |
| Date of Report | 2008-01-22 |
| Date of Event | 2008-01-18 |
| Date Facility Aware | 2008-01-22 |
| Report Date | 2008-01-22 |
| Date Mfgr Received | 2008-01-22 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2008-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANN RECKTENWALL |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5743718028 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOST OPTIONS HINGED TIBIA BASEPLATE |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2008-02-01 |
| Returned To Mfg | 2008-01-23 |
| Model Number | NA |
| Catalog Number | 502000001 |
| Lot Number | 60791538 |
| ID Number | NA |
| Device Expiration Date | 2016-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 959949 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-01 |