MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-18 for PINN CAN BONE SCREW 6.5MMX20MM 121720500 manufactured by Johnson & Johnson Medical (suzhou) Ltd. 3006356043.
[92458644]
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
[92458645]
Patient had complained of pain and was convinced by physio that the screws were rubbing on psoas muscle so requested removal of the cup screws. Patient also had abductor issues so a constrained liner was used.
Patient Sequence No: 1, Text Type: D, B5
[106441992]
(b)(4). Investigation summary: no device associated with this report was received for examination. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. 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
| Report Number | 1818910-2017-50045 |
| MDR Report Key | 7043975 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-18 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-10-24 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2011-05-10 |
| Date Added to Maude | 2017-11-18 |
| 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 | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | JJMSZ PLANT FOR STK. & N-STK. |
| Manufacturer Street | NO. 299, CHANGYANG STREET SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU, JIANGSU 215121 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215121 |
| 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 SCREW |
| Product Code | NDJ |
| Date Received | 2017-11-18 |
| Catalog Number | 121720500 |
| Lot Number | D00456060 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-18 |