MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for TRIATHLON PS X3 TIBIAL INSERT 5532-G-313 manufactured by Stryker Orthopaedics-mahwah.
[184918057]
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[184918058]
It was reported that the patient's left knee was revised due to the post of the insert breaking off. A 3x13 ps insert was revised to a 3x16 ps insert. The device is allegedly available for return, and the rep confirmed no further information is available from the hospital or surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00579 |
| MDR Report Key | 9866439 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2008-04-02 |
| 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 | MR. JUANA HICIANO |
| 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, CO |
| Product Code | MBH |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-03 |
| Model Number | 5532-G-313 |
| Catalog Number | 5532-G-313 |
| Lot Number | LNRMEE |
| Device Expiration Date | 2013-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2020-03-23 |