MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2015-04-24 for TM MONOBLOCK CUP UNK manufactured by Zimmer Tmt.
[19501181]
It was observed in a journal article titled "uncemented porous tantalum acetabular components: early follow "up and failures in 613 primary total hip arthroplasties" (attached), that of the 413 patients implanted with a tm monoblock cup implant, five (5) patients had a hematoma evacuation; however, it is unknown if the tm monoblock cup was revised. No further information was provided. Per the fda guidance draft, these patients events will be grouped into 1 mdr report based on product and similar failure type identified in the journal article.
Patient Sequence No: 1, Text Type: D, B5
[19696966]
Investigation is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005751028-2015-00055 |
| MDR Report Key | 4736697 |
| Report Source | 03,05 |
| Date Received | 2015-04-24 |
| Date of Report | 2015-04-24 |
| Date Mfgr Received | 2015-03-09 |
| Date Added to Maude | 2015-04-30 |
| 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 | 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 | TM MONOBLOCK CUP |
| Generic Name | TM MONOBLOCK CUP |
| Product Code | KWB |
| Date Received | 2015-04-24 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER TMT |
| Manufacturer Address | 10 POMEROY RD. PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-24 |