MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02 report with the FDA on 2013-09-12 for ZIMMER TRABECULAR METAL PATELLA, SINGLE PEG UNK manufactured by Zimmer.
[3933225]
The zimmer patella implant was implanted with a conformis iduo g2 bicompartmental knee implant. Fracture of the patella implant was reported. Revision surgery occurred to remove the patella implant. A partial patellectomy was performed.
Patient Sequence No: 1, Text Type: D, B5
[11112516]
Conformis clinical affairs department received a report that a study patient with an iduo g2 implant required surgical intervention to remove a fractured patella implant. The patella implant that was implanted with the iduo g2 device was not manufactured by conformis. The implanted conformis iduo g2 device does not appear to be related to this adverse event. Event description is provided in the attached report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004153240-2013-00137 |
| MDR Report Key | 3370017 |
| Report Source | 02 |
| Date Received | 2013-09-12 |
| Date of Report | 2013-08-15 |
| Date of Event | 2013-08-15 |
| Date Mfgr Received | 2013-08-15 |
| Date Added to Maude | 2013-09-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 28 CROSBY DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7813459164 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER TRABECULAR METAL PATELLA, SINGLE PEG |
| Generic Name | PATELLAR BUTTON |
| Product Code | HTG |
| Date Received | 2013-09-12 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-09-12 |