MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-10-15 for UNKNOWN_RECONSTRUCTIVE_PRODUCT UNK_REC manufactured by Stryker Orthopaedics-mahwah.
[5025100]
It was reported patient had a revision of right knee due to pain, and a loose femoral component.
Patient Sequence No: 1, Text Type: D, B5
[12363502]
The catalog number and lot code were not reported. The device was reported as an unknown size 4 cr femur. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation. Device is not available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002249697-2014-03896 |
| MDR Report Key | 4175382 |
| Report Source | 00,05 |
| Date Received | 2014-10-15 |
| Date of Report | 2014-09-22 |
| Date of Event | 2014-09-22 |
| Date Mfgr Received | 2014-09-22 |
| Date Added to Maude | 2014-10-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. SANDRA SPOKANE |
| 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 | 2014-10-15 |
| 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. Hospitalization; 2. Required No Informationntervention | 2014-10-15 |