MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-02 for UNKNOWN KNEE FEMORAL ADAPTOR BOLT UNK KNEE FEMORAL ADAPTOR BOLT manufactured by Depuy Orthopaedics Inc Us.
[181579181]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[181579182]
Tc3 bolt and adaptor broke in patient.. Outcome was a revision for tc3 femoral component. There was metal debris in the joint and the sleeve was well fixed. Surgeon removed the femoral component after 30 minutes of work.. The 5 degree adaptor was still engaged in the sleeve which we were able to break the taper with slap hammer and five grip using the bolt.... There have been multiple cases with the same problem which i have not been a part of. Surgeon was able to re-engage morse taper with an srom hinge implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-06491 |
| MDR Report Key | 9775009 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-02 |
| 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 DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN KNEE FEMORAL ADAPTOR BOLT |
| Generic Name | UNK KNEE FEMORAL ADAPTOR BOLT |
| Product Code | HTN |
| Date Received | 2020-03-02 |
| Catalog Number | UNK KNEE FEMORAL ADAPTOR BOLT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-02 |