MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-31 for PINNACLE MTL INS NEUT36IDX54OD 1218-87-354 121887354 manufactured by Depuy Orthopaedics Inc Us.
[186799217]
Product complaint # (b)(4). Us fda device mdr decision completed. The liner is reported due to legal status of pc. There is no evidence of revision or invasive treatment. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Initial reporter occupation: lawyer.
Patient Sequence No: 1, Text Type: N, H10
[186799218]
Unf and medical records received. After review of medical records, there is no revision notes provided or reported. Doi: (b)(6) 2008. Dor: none reported, (right hip).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09772 |
| MDR Report Key | 9906304 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2008-01-28 |
| Date Added to Maude | 2020-03-31 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | LEEDS MFG & MATERIAL WAREHOUSE |
| Manufacturer Street | ST ANTHONYS ROAD |
| Manufacturer City | LEEDS LS118DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8DT |
| 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 | KWA |
| Date Received | 2020-03-31 |
| Model Number | 1218-87-354 |
| Catalog Number | 121887354 |
| Lot Number | 2539319 |
| Device Expiration Date | 2013-01-31 |
| 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 | 2020-03-31 |