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 ASPHERE M SPEC 12/14 36 +1.5 1365-51-100 136551100 manufactured by Depuy Orthopaedics Inc Us.
[185980577]
(b)(4). Initial reporter occupation: lawyer. 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
[185980578]
Medical records report alval, hypersensitivity, pseudotumor, pain, tendinosis, bursitis, elevated metal ion levels, metallosis and fluid collection. The patient was then revised to address pain, pseudotumor and metal on metal reaction. A significant amount of synovial fluid was encountered within the joint along with mild or minimal amounts of trunnions and metallosis type material or tissue. Doi: (b)(6) 2010, dor: (b)(6) 2019, (right hip).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09588 |
| MDR Report Key | 9897964 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-08-21 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2009-08-31 |
| 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 | 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 INT'L LTD. 8010379 |
| Manufacturer Street | ST ANTHONYS ROAD |
| Manufacturer City | LEEDS LS118 DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8 DT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPHERE M SPEC 12/14 36 +1.5 |
| Generic Name | ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS |
| Product Code | JDI |
| Date Received | 2020-03-30 |
| Model Number | 1365-51-100 |
| Catalog Number | 136551100 |
| Lot Number | 2991399 |
| Device Expiration Date | 2014-08-31 |
| 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 |