MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-09-02 for NATURAL KNEE II METAL BACKED PATELLA 620001100 manufactured by Zimmer, Inc..
[20782389]
It is reported that the patient received an implant in (b)(6) 2007. She fell a few years ago and has been experiencing discomfort and swelling. After conservative treatment, the doctor performed an arthroscopy and it was determined that the patella component was worn. The patient was subsequently revised.
Patient Sequence No: 1, Text Type: D, B5
[20960361]
Information was received from a distributor who is not required to complete form 3500a. This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2014-01050 |
| MDR Report Key | 4076412 |
| Report Source | 05,08 |
| Date Received | 2014-09-02 |
| Date of Report | 2014-08-05 |
| Date of Event | 2014-07-30 |
| Date Mfgr Received | 2014-08-05 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2014-09-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN ESCAPULE |
| Manufacturer Street | PO BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATURAL KNEE II METAL BACKED PATELLA |
| Generic Name | NONE |
| Product Code | HTG |
| Date Received | 2014-09-02 |
| Catalog Number | 620001100 |
| Lot Number | 60608304 |
| Device Expiration Date | 2011-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | PO BOX 708 WARSAW IN 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-02 |