MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-30 for SUMMIT DUOFIX TAP SZ7 HI OFF 1570-12-135 157012135 manufactured by Depuy Orthopaedics Inc Us.
[186764592]
(b)(4). Initial reporter occupation: lawyer. (b)(4). 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
[186764593]
Litigation alleges pain, discomfort, emotional distress, disability and disfigurement. In addition to what was previously alleged, pfs alleges, limited ability to walk, elevated metal ions, mental anguish and anxiety. After review of medical records, it was mentioned on radiology report that the patient had a fall, no fracture was noted on x-ray, however, mri on (b)(6) 2018 reported greater trochanteric fracture. The stem has been added to the complaint. Added relevant lab, patient height and weight. Doi: (b)(6) 2009; dor: (b)(6) 2019; right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09630 |
| MDR Report Key | 9900455 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2020-03-30 |
| 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 | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUMMIT DUOFIX TAP SZ7 HI OFF |
| Generic Name | SUMMIT HIP STEM : HIP FEMORAL STEM |
| Product Code | LPH |
| Date Received | 2020-03-30 |
| Model Number | 1570-12-135 |
| Catalog Number | 157012135 |
| Lot Number | C66EM1000 |
| 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 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |