MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-01-02 for PINN CAN BONE SCREW 6.5MMX35MM 121735500 manufactured by Depuy Orthopaedics Inc Us.
[131778465]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131778466]
Complaint description: (b)(6) 2017: litigation alleges discomfort, pain, stiffness, loss of motion, elevated cobalt-chromium metal ions, loosening, metallosis, necrosis, and soft tissue damage. Update (b)(6) 2017: pfs and medical records received. In addition to what was previously alleged, pfs alleges misalignment, limp, poor balance, and instability. After review of medical records, it was reported that the patient was revised to address subsidence. Updated part and lot information. Update ad 07 may 2018 the receipt of ppf and sticker sheets. In addition to what were previously alleged, ppf alleges loosening of cup and metal wear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-79507 |
| MDR Report Key | 8208024 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-06 |
| Date of Event | 2015-05-21 |
| Date Mfgr Received | 2019-08-09 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2019-01-02 |
| 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 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655 |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN CAN BONE SCREW 6.5MMX35MM |
| Generic Name | BONE SCREWS AND PINS : SCREWS |
| Product Code | NDJ |
| Date Received | 2019-01-02 |
| Catalog Number | 121735500 |
| Lot Number | D14021740 |
| 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 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-02 |