MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-15 for BIGLIANI/FLATOW COMPLETE SHOULDER 07-100-????? manufactured by Zimmer Tmt.
[794827]
The patient suffered a traumatic event, when he attempted to catch a falling table, which weighed greater than 200 lbs. Radiographic evaluation of the patient subsequent to the event revealed that the implant had fractured. The patient was successfully revised.
Patient Sequence No: 1, Text Type: D, B5
[8093461]
The implant was retained by the surgeon and not returned for evaluation. The description of the event indicates that the physical trauma experienced by the patient caused the device to fracture.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005751028-2008-00002 |
| MDR Report Key | 1000173 |
| Report Source | 05 |
| Date Received | 2008-02-15 |
| Date of Report | 2008-02-15 |
| Date of Event | 2008-01-22 |
| Date Mfgr Received | 2008-01-18 |
| Date Added to Maude | 2008-02-25 |
| 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 ROAD |
| Manufacturer City | PARSIPPANY NJ 07075 |
| Manufacturer Country | US |
| Manufacturer Postal | 07075 |
| 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 | 2008-02-15 |
| Catalog Number | 07-100-????? |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 969968 |
| Manufacturer | ZIMMER TMT |
| Manufacturer Address | 10 POMEROY ROAD PARSIPPANY NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-15 |