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 2020-03-26 for TRIATHLON PS X3 TIBIAL INSERT 5532-G-809-E manufactured by Stryker Orthopaedics-mahwah.
[188212781]
An event regarding infection involving a triathlon insert was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as product was not returned. Clinician review: no medical records were received for review with a clinical consultant. Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies. Complaint history review: no other similar events were reported for the lot or sterile lot referenced. Conclusion: the exact cause of the event could not be determined because insufficient information was provided. Additional information including pathology reports, operative reports, progress notes, x- rays and return of the device are needed to fully investigate the event. Infection is a known possible adverse outcome of surgery, as noted in the instructions for use. All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards. When the sterile barrier of any device is opened, the sterility of that device becomes a function of handling and surgical technique and is beyond stryker? S control. Infection due to bacterial contamination, as supplied from the manufacturer, is an extremely rare event (see technical report 0000128012). If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened. The following devices were also listed in this report: triathlon ps fem comp #8r-cem; cat# 5515f802; lot# aem4f, tri ts baseplate size 8; cat# 5521-b-800; lot# d4l3oa, triathlon asymmetric x3 patella; cat# 5551-g-401; lot# x685, simplex p - us full dose 10-pk; cat# 61911010; lot# rea068, simplex p - us full dose 10-pk; cat# 61911010; lot# rea068. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Patient Sequence No: 1, Text Type: N, H10
[188212782]
As reported: "patient's right knee was revised due to infection. This is the second revision of the patient's right knee. Revision 1 was a poly swap. All information the hospital has on the patient is attached to this email. " rep provided primary and revision usage sheets.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00605 |
| MDR Report Key | 9884115 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-01-28 |
| 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. COLLIN NEITZEL |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| 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 | TRIATHLON PS X3 TIBIAL INSERT |
| Generic Name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C |
| Product Code | MBH |
| Date Received | 2020-03-26 |
| Model Number | 5532-G-809-E |
| Catalog Number | 5532-G-809-E |
| Lot Number | 8248PD |
| 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 |