MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-03-05 for AS INVERSE GLENOID FIXATION 0104223200 manufactured by Zimmer Gmbh.
[20345364]
Anatomic inverse baseplate did not ingrow and loosened with screw fracture. Required revision to trabecular metal baseplate.
Patient Sequence No: 1, Text Type: D, B5
[20403944]
Other device used: catalog # 0104223236, as inverse glenoid head 36, lot # 2321197. Catalog # 0104223024, inverse/reverse screw 24, lot #2324281. Catalog # 0104223036, inverse/reverse screw 36, lot # 2294899 (failure code 1069). A check of the manufacturing papers of all mentioned products showed no deviations of the specifications. This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2008-00005 |
| MDR Report Key | 1005690 |
| Report Source | 05,08 |
| Date Received | 2008-03-05 |
| Date of Report | 2008-01-31 |
| Date of Event | 2008-01-29 |
| Date Facility Aware | 2008-01-31 |
| Report Date | 2008-01-31 |
| Date Mfgr Received | 2008-01-31 |
| Date Added to Maude | 2008-03-07 |
| 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 | CHRISOF MUELLER |
| Manufacturer Street | SULZER ALLEE 8 |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8404 |
| Manufacturer Phone | 522627210 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AS INVERSE GLENOID FIXATION |
| Generic Name | ANATOMICAL SHOULDER INVERSE/REVERSE |
| Product Code | KYM |
| Date Received | 2008-03-05 |
| Model Number | NA |
| Catalog Number | 0104223200 |
| Lot Number | 2317779 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 975320 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 WINTERTHUR SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-03-05 |