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 2020-01-13 for PINNACLE MTL INS NEUT36IDX54OD 1218-87-354 121887354 manufactured by Depuy Orthopaedics Inc Us.
[174728480]
(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
[174728481]
It was reported that the patient had a painful metal on metal hip. We couldn? T see the part number on the head ball. He converted it to a ceramic on poly. No further information is available. Doi: (b)(6) 2012. Dor: (b)(6) 2019; right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-01583 |
| MDR Report Key | 9581707 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-26 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2006-05-05 |
| Date Added to Maude | 2020-01-13 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY INT'L LTD. 8010379 |
| Manufacturer Street | ST ANTHONYS ROAD |
| Manufacturer City | LEEDS LS118 DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8 DT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINNACLE MTL INS NEUT36IDX54OD |
| Generic Name | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS |
| Product Code | OVO |
| Date Received | 2020-01-13 |
| Model Number | 1218-87-354 |
| Catalog Number | 121887354 |
| Lot Number | 2155112 |
| 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 | 2020-01-13 |