MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-12 for UNKNOWN DEPUY VERSION ROD UNK-EXTREM manufactured by Depuy Orthopaedics, Inc..
[89704604]
Complete product detail has not been received at this time. If further information is received a follow-up medwatch will be filed as appropriate. 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
[89704605]
It was reported that the rotation indicated by the version rod did not match the humeral head anatomy and the placement of the cutting guide with the kit in question was indicating an incorrect cut. When the alternative kit was opened and used on the same patient in the same way, the cut was positioned correctly with regards to the patients anatomy. There is no obvious defect with the kit however the hospital have requested that this kit is swapped out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2017-26388 |
| MDR Report Key | 6943536 |
| Date Received | 2017-10-12 |
| Date of Report | 2017-09-12 |
| Date of Event | 2017-09-12 |
| Date Mfgr Received | 2017-09-12 |
| Date Added to Maude | 2017-10-12 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| 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 | 0 |
| Brand Name | UNKNOWN DEPUY VERSION ROD |
| Generic Name | SHOULDER INSTRUMENT/TRIAL |
| Product Code | MJT |
| Date Received | 2017-10-12 |
| Catalog Number | UNK-EXTREM |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-12 |