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 2019-05-06 for HMRS DISTAL FEMUR RIGHT 12OMM 63671112 manufactured by Stryker Orthopaedics-mahwah.
[144179987]
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[144179988]
At (b)(6) 2008, hmrs placement of knee was performed by tumor resection. About 10 years after the surgery, the clip was pop out naturally from hmrs axis pin and pin was protruded from the femur component. Therefore, the revision surgery was done and the groove in which the clip fits was worn and could not fix the clip. Therefore, femur component, pin, clip and other attached parts were changed the new same devices. Dr 's request to check the wear of the clip groove in the femoral component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2019-01857 |
| MDR Report Key | 8583621 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2019-05-06 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-04-08 |
| Date Mfgr Received | 2019-05-31 |
| Device Manufacturer Date | 2008-01-30 |
| Date Added to Maude | 2019-05-06 |
| 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-LIMERICK |
| Manufacturer Street | RAHEEN BUSINESS PARK |
| Manufacturer City | LIMERICK NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HMRS DISTAL FEMUR RIGHT 12OMM |
| Generic Name | KNEE IMPLANT |
| Product Code | NPJ |
| Date Received | 2019-05-06 |
| Catalog Number | 63671112 |
| Lot Number | SFFEF1 |
| Device Expiration Date | 2013-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-05-06 |