MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08,distributor,health prof report with the FDA on 2015-05-11 for NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 6 05-121-16141 manufactured by Zimmer Trabecular Metal Technology.
[19347713]
It was reported that the patient is experiencing twisting, popping and knee giving out, causing falls. The patient received a tm monoblock lps tibia on (b)(6) 2011; however, it is unknown if the patient was revised. No further information was received.
Patient Sequence No: 1, Text Type: D, B5
[19524747]
Investigation is in progress.
Patient Sequence No: 1, Text Type: N, H10
[60320605]
The tm monoblock tibia was manufactured, inspected and packaged within established process specifications. The femoral and tibial components were found to be compatible. No x-rays, reports or the device itself were provided for this investigation. As a result, the cause of the issues reported by the patient could not concluded. This investigation is considered closed at this time; however, should additional information become available, this report shall be update.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005751028-2015-00065 |
| MDR Report Key | 4772278 |
| Report Source | 05,08,DISTRIBUTOR,HEALTH PROF |
| Date Received | 2015-05-11 |
| Date of Report | 2015-05-11 |
| Date Mfgr Received | 2015-04-16 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2015-05-15 |
| 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 | ANAND SINGH |
| Manufacturer Street | 10 POMEROY RD. |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9735760032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 6 |
| Generic Name | TM MONOBLOCK TIBIA |
| Product Code | HSH |
| Date Received | 2015-05-11 |
| Catalog Number | 05-121-16141 |
| Lot Number | 60708555 |
| Device Expiration Date | 2012-07-31 |
| 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 TRABECULAR METAL TECHNOLOGY |
| Manufacturer Address | 10 POMEROY RD. PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-11 |