MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-18 for BIGLIANI/FLATOW COMPLETE SHOULDER 07-100-04461 manufactured by Zimmer Tmt.
[824426]
While performing a revision surgery to repair a previously repaired fracture (peri prosthetic fracture repaired with a locked synthes plate), the glenoid was discovered to be loose. Due to the health and activity level of the pt, the physician elected to implant a long stemmed hemiarthroplasty.
Patient Sequence No: 1, Text Type: D, B5
[7990637]
Investigation in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005751028-2008-00004 |
| MDR Report Key | 1015029 |
| Report Source | 05 |
| Date Received | 2008-03-18 |
| Date of Report | 2008-03-18 |
| Date of Event | 2008-02-13 |
| Date Mfgr Received | 2008-02-18 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2008-03-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BILL HARA |
| Manufacturer Street | 10 POMEROY RD. |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 2018181800 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-023/030-6 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIGLIANI/FLATOW COMPLETE SHOULDER |
| Generic Name | GLENOID COMPONENT |
| Product Code | KYM |
| Date Received | 2008-03-18 |
| Catalog Number | 07-100-04461 |
| Lot Number | 721031-2 |
| Device Expiration Date | 2008-01-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 985640 |
| Manufacturer | ZIMMER TMT |
| Manufacturer Address | 10 POMEROY RD. PARSIPPANY NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-03-18 |