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 2015-08-26 for UNKNOWN_RECONSTRUCTIVE_PRODUCT UNK_REC manufactured by Stryker Orthopaedics-mahwah.
[24086778]
Catalogue number unknown at this time. Device description reported as an unknown duracon non beaded baseplate. An evaluation of the device cannot be performed as the device and medical records were not made available to the manufacturer due to hospital policy. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. Not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[24086779]
It was reported that the patient had an event getting into or out of the shower and presented with pain. Surgeon revised the patient's right duracon tibial baseplate and poly as the baseplate was found to be cracked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-02786 |
| MDR Report Key | 5031364 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2015-08-26 |
| Date of Report | 2015-07-29 |
| Date of Event | 2015-07-29 |
| Date Mfgr Received | 2015-07-29 |
| Date Added to Maude | 2015-08-26 |
| 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. JADWIGA DEGRADO |
| 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 | UNKNOWN_RECONSTRUCTIVE_PRODUCT |
| Generic Name | IMPLANT |
| Product Code | HSH |
| Date Received | 2015-08-26 |
| Catalog Number | UNK_REC |
| 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. Required No Informationntervention | 2015-08-26 |