MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-18 for LINK ENDO-MODELL TIBIAL PLATEAU SETS AND REPLACEMENT SETS, ALL SIZES 15-0027/11 15-0027/12 15-0027/13 15-0027/14 15-002 15-0027/11 15-0027/12 15-0027/ manufactured by Waldemar Link Gmbh Co. Kg.
[24202446]
As a precaution each delivery of "link endo-modell tibial plateau sets" and "link endo-modell replacement sets" contains one tibial plateau with the old pin/hole fitting and one tibial plateau with the new dovetail-shaped incision. The tibial plateau of the old form cannot be combined with a tibial component of the new form combined, and vice versa. Due to a complaint, occurred in (b)(6), we have determined in our process eval that it is possible that two tibial plateaus of the old or the new form are contained in the "endo-modell tibial plateau sets" or "endo-modell replacement sets" and not as intended, one tibial plateau of the old form with hole for pinhole protection and one tibial plateau of the new common form with the dovetail-shaped incision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004371426-2015-00005 |
| MDR Report Key | 5015834 |
| Date Received | 2015-08-18 |
| Date Added to Maude | 2015-08-19 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Street | OSTSTRASSE 410 |
| Manufacturer City | NORDERSTEDT |
| Manufacturer Country | DE |
| Manufacturer G1 | WALDEMAR LINK GMBH CO. KG |
| Manufacturer Street | OSTSTRASSE 410 |
| Manufacturer City | NORDERSTEDT |
| Manufacturer Country | DE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LINK ENDO-MODELL TIBIAL PLATEAU SETS AND REPLACEMENT SETS, ALL SIZES |
| Generic Name | LINK ENDO-MODELL TIBIAL PLATEAU SETS" AND "LINK ENDO-MODELL REPLACEMENT SETS |
| Product Code | HSA |
| Date Received | 2015-08-18 |
| Model Number | 15-0027/11 15-0027/12 15-0027/13 15-0027/14 15-002 |
| Catalog Number | 15-0027/11 15-0027/12 15-0027/ |
| Lot Number | ALL LOTS/ SN'S IN 2015 |
| Device Expiration Date | 2015-12-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| 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. Other | 2015-08-18 |