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 2020-03-19 for CERAMAX CERAMIC INSERT 28 X 48 1218-89-648 121889648 manufactured by Depuy Orthopaedics Inc Us.
[184169854]
Product complaint #: (b)(4). (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
[184169855]
It was reported that the liner broke at the rim. The remaining liner became stuck in the shell. The shell and the liner had to be removed together. On the back table, the shell and the liner were still stuck together. A new cup and a ne liner were used to complete the case. It was believed that the liner may be defective. No harm to the patient occurred, but there was a five-minute surgical delay. Doe: (b)(6) 2020. Right hip
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-08671 |
| MDR Report Key | 9856481 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2018-12-01 |
| Date Added to Maude | 2020-03-19 |
| 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 IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | CORK MFG & MATERIAL WAREHOUSE |
| Manufacturer Street | LOUGHBEG RINGASKIDDY CO. |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERAMAX CERAMIC INSERT 28 X 48 |
| Generic Name | PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS |
| Product Code | MRA |
| Date Received | 2020-03-19 |
| Model Number | 1218-89-648 |
| Catalog Number | 121889648 |
| Lot Number | 8988779 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-19 |