MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-19 for UNKNOWN TRIATHLON KNEE INSERT UNK_JR manufactured by Stryker Orthopaedics-mahwah.
[184915353]
The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time due to the ongoing litigation. Should additional information become available, the evaluation summary will be submitted in a supplemental report. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[184915354]
Information received from legal that the patient's right knee was revised due to infection. The poly was removed and a temporary spacer was placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00568 |
| MDR Report Key | 9857955 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2016-02-03 |
| Date Mfgr Received | 2020-02-20 |
| 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 | MS. MARGARET FOLEY |
| Manufacturer Street | RAHEEN BUSINESS PARK |
| Manufacturer City | LIMERICK NA |
| Manufacturer Country | IE |
| Manufacturer Postal | NA |
| Manufacturer Phone | 61498200 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN TRIATHLON KNEE INSERT |
| Generic Name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO |
| Product Code | MBH |
| Date Received | 2020-03-19 |
| Catalog Number | UNK_JR |
| Lot Number | UNKNOWN |
| 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 | 2020-03-19 |