MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for ATTUNE LCS manufactured by Depuy Orthopaedics, Inc.
[184846527]
Patient in operating room for right total knee arthroplasty. During case in process, i was informed that ps fem trial sz 5l broke in half after doctor hammered trail in place. Both pieces were removed per surgeon. Doctors and rns removed all pieces removed from patient. Depuy rep was present and aware. Depuy rep took picture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9877386 |
| MDR Report Key | 9877386 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-17 |
| Report Date | 2020-02-20 |
| Date Reported to FDA | 2020-02-20 |
| Date Reported to Mfgr | 2020-03-25 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTUNE LCS |
| Generic Name | INSTRUMENT, CUTTING, ORTHOPEDIC |
| Product Code | HTZ |
| Date Received | 2020-03-25 |
| Model Number | ATTUNE |
| Lot Number | D254500725 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC |
| Manufacturer Address | 700 ORTHOPAEDIC DR WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |