MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2018-10-08 for TIBIAL COMP KIN HINGE KNEE 64753933 manufactured by Stryker Orthopaedics-mahwah.
[123045448]
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[123045449]
On (b)(6) 2018, there was no problem when visiting outpatients in the morning. My knee suddenly became unstable from the afternoon and went to a nearby hospital. Visited the original hospital again after observing about 3 months. On september 27, 2018, it was confirmed that reoperation was carried out and it was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2018-03237 |
| MDR Report Key | 7945675 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2018-10-08 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-09-11 |
| Date Added to Maude | 2018-10-08 |
| 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 | MR. KEYLA COLON |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-LIMERICK |
| Manufacturer Street | RAHEEN BUSINESS PARK |
| Manufacturer City | LIMERICK NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIBIAL COMP KIN HINGE KNEE |
| Generic Name | KNEE JOINT FEMOROTIBIAL METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS. |
| Product Code | LGE |
| Date Received | 2018-10-08 |
| Catalog Number | 64753933 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-10-08 |