MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-12-17 for PINN CAN BONE SCREW 6.5MMX25MM 121725500 manufactured by Depuy Orthopaedics, Inc. 1818910.
[130472223]
(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). Reporter is an attorney.
Patient Sequence No: 1, Text Type: N, H10
[130472224]
Patient was revised to address cup loosening. Update ad 27 jun 2018: receipt of ppf and sticker sheets. In addition to what were previously alleged, ppf alleges constrained liner. Added bone screw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2018-78361 |
| MDR Report Key | 8168804 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-12-17 |
| Date of Report | 2018-11-22 |
| Date of Event | 2014-03-28 |
| Date Mfgr Received | 2018-11-22 |
| Device Manufacturer Date | 2005-03-17 |
| Date Added to Maude | 2018-12-17 |
| 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 | 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 6.5MMX25MM |
| Generic Name | BONE SCREWS AND PINS : SCREWS |
| Product Code | NDJ |
| Date Received | 2018-12-17 |
| Catalog Number | 121725500 |
| Lot Number | ZJ5C14000 |
| Device Expiration Date | 2015-03-31 |
| 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. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-17 |