MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08,distributor,health prof report with the FDA on 2015-06-19 for UNKNOWN ROTATING HINGE KNEE FEMORAL manufactured by Zimmer Inc.
[5812691]
It is reported that patient was revised due to broken hinge mechanism on the femoral component. The tibial component was also revised due to possible loosening.
Patient Sequence No: 1, Text Type: D, B5
[13472366]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[62391110]
Device history records could not be reviewed as the part and lot numbers are unknown. This device is used for treatment. In the returned x-rays it appears as though there is a piece of debris distal to the femoral component. It was reported that the tibial component was revised for loosening and once the knee was opened it was seen that the portion of the hinge that holds the hinge mechanism to the femoral component fractured and the broken parts were removed or replaced. The package insert states that "because the rotating hinge knee is a highly constrained device, the risk of component breakage, loosening and polyethylene wear may be greater than for less constrained knee implants". Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. A definitive root cause cannot be determined with the information provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2015-00942 |
| MDR Report Key | 4861491 |
| Report Source | 05,08,DISTRIBUTOR,HEALTH PROF |
| Date Received | 2015-06-19 |
| Date of Report | 2015-05-18 |
| Date of Event | 2015-05-13 |
| Date Mfgr Received | 2015-07-13 |
| Date Added to Maude | 2015-06-24 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ROTATING HINGE KNEE FEMORAL |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2015-06-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER INC |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-19 |