MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-19 for ENDO-MODEL M MODULAR STEM 15-2950/05 manufactured by Waldemar Link Gmbh & Co. Kg.
[188265331]
It was reported that a revision surgery was performed due to fracture of the modular knee stem at the taper junction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004371426-2020-00002 |
| MDR Report Key | 9851856 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2020-03-19 |
| 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 | REBEKKA WINTERHOFF |
| Manufacturer Street | BARKHAUSENWEG 10 |
| Manufacturer City | HAMBURG, 22339 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22339 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO-MODEL M MODULAR STEM |
| Generic Name | KNEE STEM |
| Product Code | KRO |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-02-28 |
| Catalog Number | 15-2950/05 |
| Lot Number | 0451050 |
| Device Expiration Date | 2010-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WALDEMAR LINK GMBH & CO. KG |
| Manufacturer Address | BARKHAUSENWEG 10 HAMBURG, 22339 GM 22339 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |