MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-02-21 for UNKNOWN KNEE FEMORAL ADAPTOR BOLT UNK KNEE FEMORAL ADAPTOR BOLT manufactured by Depuy Orthopaedics Inc Us.
[188690367]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188690368]
The literature article entitled? Metaphyseal sleeves in revision total knee arthroplasty: minimum seven-year follow-up study? , written by sanjeev agarwal, et al. Published in the knee 25 (2018) 1299-1307, https://doi. Org/10. 1016/j. Knee. 2018. 09. 010, was reviewed. The purpose of the article was to report early results with the use of metal, porous coated metaphyseal sleeves in revision knee replacements. The authors present seven years of follow-up of the initial cohort. This is, as of yet, the longest follow-up report in literature. Products used: pfc & tc3, depuy index revision indications (figure 1): - aseptic loosening -infection -stiffness (four of these patients were revised to a noiles, depuy and underwent manipulations under anesthesia with continued restricted flexion); one patient was in her mid-40? S during index revision and had two further re-revisions for stiffness (these will be combined together due to insufficient information regarding the revisions), developed late infection four years after third revision and recently, in her mid-50? S opted for a two-stage arthrodesis-it is reasonable to conclude that this late infection four years after the last revision was not related to the implant -pain -instability re-revision indications (figure 1): -aseptic loosening (one patient revised for loosening had disengagement at the stem sleeve junction secondary to a technical error of tight fit of stem in femoral diaphysis) - infection (two-stage procedure, transfemoral amputation, distal femoral replacement prosthesis used for reconstruction, antibiotic suppression therapy) -persistent pain -instability other notes: figure 3 reports migration of the tibial component (radiographic images) table 1 shows degree of bone loss in femur and tibia. The discussion section mentions multiple further procedures including amputation. The article does not discuss patellar resurfacing or cement manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-05638 |
| MDR Report Key | 9739223 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-10 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DR |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | JTE WARSAW MFG SITE |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN KNEE FEMORAL ADAPTOR BOLT |
| Generic Name | KNEE FEMORAL ADAPTOR BOLT |
| Product Code | HTN |
| Date Received | 2020-02-21 |
| Catalog Number | UNK KNEE FEMORAL ADAPTOR BOLT |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-21 |