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 2020-02-14 for MODULAR CATHCART BALL 49MM OD 1363-49-000 136349000 manufactured by Depuy Orthopaedics Inc Us.
[188812609]
(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
[188812610]
It was reported that the hip dislocated and could not be reduced, so the patient was opened and the surgeon pulled the stem out with little effort. It was indicated that there was loosening of the stem at the bone to implant interface. Doi: (b)(6) 2019. Dor: (b)(6) 2020. Right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-04855 |
| MDR Report Key | 9711178 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-06-28 |
| Date Added to Maude | 2020-02-14 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW PA 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | JJM (SUZHOU) LTD. 3006356043 |
| Manufacturer Street | NO.299 CHANGYANG ST SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU JIANGSU 21512-6 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 21512-6 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MODULAR CATHCART BALL 49MM OD |
| Generic Name | HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI |
| Product Code | LZY |
| Date Received | 2020-02-14 |
| Model Number | 1363-49-000 |
| Catalog Number | 136349000 |
| Lot Number | D19062485 |
| 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 ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-14 |