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 2019-01-22 for STAND CUP TRIAL D42 +6MM 230742406 manufactured by Depuy France Sas 3003895575.
[133842168]
(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
[133842169]
It was reported that the humeral cup trials have shaving of plastic coming off of them. Had to open three different trays for case. All went well and nothing left in patient.
Patient Sequence No: 1, Text Type: D, B5
[134386877]
(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
| Report Number | 1818910-2019-81862 |
| MDR Report Key | 8269059 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-03 |
| Date of Event | 2019-01-03 |
| Date Mfgr Received | 2019-01-31 |
| Device Manufacturer Date | 2015-10-27 |
| Date Added to Maude | 2019-01-22 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER IN 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE B.P. 256 |
| 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 | STAND CUP TRIAL D42 +6MM |
| Generic Name | EXTREMITY INSTRUMENTS : HUMERAL TRIALS |
| Product Code | LHX |
| Date Received | 2019-01-22 |
| Returned To Mfg | 2019-01-22 |
| Catalog Number | 230742406 |
| Lot Number | 5259017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY FRANCE SAS 3003895575 |
| Manufacturer Address | 7 ALL?E IR?NE JOLIOT CURIE BP 256 SAINT PRIEST CEDEX 69801 FR 69801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-22 |