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 PINN CAN BONE SCREW 6.5MMX25MM 1217-25-500 121725500 manufactured by Depuy Orthopaedics Inc Us.
[187725477]
Product complaint # (b)(4). Initial reporter occupation: legal. (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
[187725478]
It was reported that the patient had pain in his left hip, black substance between head and trunnion. (2) 6. 5 pinnacle screws were removed as well. After review of medical records, the patient was revised to address pain. Intraoperative findings reported a large amount of fluid that came from the iliopsoas bursa. There was extensive corrosion between the cobalt chrome aml stem and the cobalt chrome ball. There was also extensive corrosion on the back of the metal insert between the insert and the depuy shell. There was also metallic debris around the trunnion. The screws removed from the acetabulum as their utility had long since passed and shouldn't complicate for the polyethylene bearing. The 2 unknown hip implant and unknown stem were updated. Cup and 1 screw were added due to revision findings. Doi: (b)(6) 2009. Dor: (b)(6) 2019; left hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09625 |
| MDR Report Key | 9900470 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2019-07-11 |
| Date of Event | 2019-07-10 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2009-06-08 |
| 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 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 | LPH |
| Date Received | 2020-03-30 |
| Model Number | 1217-25-500 |
| Catalog Number | 121725500 |
| Lot Number | DW7CE4000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |