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 2020-03-23 for UNKNOWN TRIATHLON TKA UNK_JR manufactured by Stryker Orthopaedics-mahwah.
[185043698]
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
[185043699]
This pi is for the revision of the patient's primary knee. During follow-up for an intra-op event which occurred on (b)(6) 2020, the rep indicated the following: "the patient's primary implant was a triathlon tka. I do not have the date of implantation. The first revision and second surgery was a competitor hinged construct. " the rep does not have access to any further information as the primary and subsequent revisions were done by unknown surgeons in unknown facilities. The revision took place approximately 3 years prior to this procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00585 |
| MDR Report Key | 9866543 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2017-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-23 |
| 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 TKA |
| Generic Name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO |
| Product Code | MBH |
| Date Received | 2020-03-23 |
| 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 | 2020-03-23 |