MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2015-02-17 for TM ACETABULAR AUGMENT UNK manufactured by Zimmer Trabecular Metal Technology.
[5510742]
It was reported in a journal article titled: "trabecular metal augments for the management of paprosky type iii defects without pelvic discontinuity", that 4 patients who had received tm acetabular augments, were revised due to loosening of the tm components and required revision surgeries.
Patient Sequence No: 1, Text Type: D, B5
[12809769]
Investigation is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005751028-2015-00009 |
| MDR Report Key | 4532508 |
| Report Source | 03,05 |
| Date Received | 2015-02-17 |
| Date of Report | 2015-02-17 |
| Date Mfgr Received | 2015-01-23 |
| Date Added to Maude | 2015-02-23 |
| 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 ACETABULAR AUGMENT |
| Generic Name | TM ACETABULAR AUGMENT |
| Product Code | KWB |
| Date Received | 2015-02-17 |
| 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 TRABECULAR METAL TECHNOLOGY |
| Manufacturer Address | 10 POMEROY RD. PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-17 |