MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-20 for FEM RASP TRIAL CO/FJD T11 L93211 manufactured by Depuy France Sas - 3003895575.
[114803542]
Product complaint # (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
[114803543]
It was reported that the size 11 femoral broach was used and it was flush, but when put the size 11 implant was proud by 5mm. Mismatched between the broach and the implant.
Patient Sequence No: 1, Text Type: D, B5
[117183898]
This product was reported in error. No patient death, serious injury or evidence of reportable product malfunction occurred. Depuy considers the investigation closed at this time. Should any additional information be received to change? The outcome of the performed investigation, the complaint will be re-opened. Product complaint # : (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2018-64871 |
| MDR Report Key | 7706108 |
| Date Received | 2018-07-20 |
| Date of Report | 2018-06-26 |
| Date Mfgr Received | 2018-08-10 |
| Device Manufacturer Date | 2003-10-23 |
| Date Added to Maude | 2018-07-20 |
| 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 | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| 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 | FEM RASP TRIAL CO/FJD T11 |
| Generic Name | MISCELLANEOUS JOINT INSTRUMENTS : CUTTING INSTRUMENTS |
| Product Code | EKD |
| Date Received | 2018-07-20 |
| Catalog Number | L93211 |
| Lot Number | 1358920 |
| 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 FRANCE SAS - 3003895575 |
| Manufacturer Address | 7 ALLEE IRENE JOLIOT-CURIE B.P. 256 SAINT PRIEST CEDEX 69801 FR 69801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-20 |