MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-12-20 for PINN CAN BONE SCREW 6.5MMX40MM 121740500 manufactured by Depuy Orthopaedics Inc Us.
[130986862]
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. Reporter is an attorney. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130986863]
Litigation papers allege that the patient has suffered pain, swelling, lack of mobility, damage to surrounding tissue and bone caused by inflammation, metallosis, pseudotumours, bursitis, and bone erosion. Doi: (b)(6) 2004 - dor: none reported (unknown side); doi: (b)(6) 2005 - dor: none reported (unknown side). Patient is a resident of (b)(6). Update ad 29 jun 2018: wpc (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record. In addition to what were previously alleged, ppf alleges loosening of cup. Added cup and screw due to this allegation. Account name, facility name, birth and revision date, implant site, surgeon contact as well as product details were also added. Corrected patient identifier and event date. Doi: (b)(6) 2004 - dor: (b)(6) 2011 (left hip) patient is bilateral, please see (b)(4) for the right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2018-78819 |
| MDR Report Key | 8184025 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-12-20 |
| Date of Report | 2018-11-30 |
| Date of Event | 2011-07-11 |
| Date Mfgr Received | 2018-11-30 |
| Device Manufacturer Date | 2002-01-06 |
| Date Added to Maude | 2018-12-20 |
| 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 6.5MMX40MM |
| Generic Name | BONE SCREWS AND PINS : SCREWS |
| Product Code | NDJ |
| Date Received | 2018-12-20 |
| Catalog Number | 121740500 |
| Lot Number | WA6AS1062 |
| Device Expiration Date | 2007-01-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Required No Informationntervention | 2018-12-20 |