MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-26 for NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM 5537-G-516 manufactured by Stryker Orthopaedics-mahwah.
[186560990]
An investigation is being performed in an attempt to identify the cause of the event. Should additional information become available it will be reported in a supplemental report. The following devices were also listed in this report: triathlon femoral distal augment 5mm - size 5 left; cat# 5540-a-501; lot# di37u. Triathlon femoral distal augment 5mm - size 5 left; cat# 5540-a-501; lot# di37u. Tri press-fit stem 16mm x 100mm; cat# 5565-s-016; lot# 0039973g. Tri ts baseplate size 5; cat# 5521-b-500; lot# dzu3ta. Triathlon sym cone aug sz b; cat# 5549-a-120; lot# apha. Tri lm/rl tib aug sz5 10mm; cat# 5546-a-501; lot# erend2a. Tri rm/ll tib aug sz5 10mm; cat# 5546-a-502; lot# erewy5d. Tri cemented stem 12mmx100mm; cat# 5560-s-212; lot# 0088207l. Triathlon femoral component; cat# 5512-f-501; lot# b3d3e. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[186560991]
It was reported that the patient's left knee was revised due to infection. All components were removed and a static antibiotic spacer was placed. Rep provided the primary and revision (spacer) usage sheets, explant pictures, and reported that no further information will be released by the hospital or surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00602 |
| MDR Report Key | 9882267 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2018-10-26 |
| Date Added to Maude | 2020-03-26 |
| 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. JOANNE MAHONY |
| Manufacturer Street | IDA INDUSTRIAL ESTATE |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Country | IE |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532800 |
| 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 | NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM |
| Generic Name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO |
| Product Code | MBH |
| Date Received | 2020-03-26 |
| Model Number | 5537-G-516 |
| Catalog Number | 5537-G-516 |
| Lot Number | D92Y33 |
| 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 | 2020-03-26 |