MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2019-04-22 for PINN CAN BONE SCREW 6.5MMX20MM 121720500 manufactured by Depuy Orthopaedics, Inc. 1818910.
[142605689]
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device was used for treatment, not diagnosis. Initial reporter occupation: non-healthcare professional "attorney" (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142605690]
Patient was revised to address significant metallosis and osteolysis, and pain for over one (1) year. Update in addition to previously reported allegations, it is now alleged that the patient suffers from a grossly loose acetabular cup. Update in addition to what was previously alleged, ppf alleges pseudotumor and metal wear. Doi: (b)(6) 2003; dor: (b)(6) 2010; left hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-91118 |
| MDR Report Key | 8535292 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2019-04-22 |
| Date of Report | 2010-11-01 |
| Date of Event | 2010-11-01 |
| Date Mfgr Received | 2019-03-27 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2019-04-22 |
| 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 PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN CAN BONE SCREW 6.5MMX20MM |
| Generic Name | BONE SCREWS AND PINS : SCREWS |
| Product Code | NDJ |
| Date Received | 2019-04-22 |
| Catalog Number | 121720500 |
| Lot Number | X2EEJ1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-22 |