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 APEX HOLE ELIM POSITIVE STOP 1246-03-000 124603000 manufactured by Depuy Orthopaedics Inc Us.
[187715742]
Product complaint # (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
[187715763]
Litigation alleges that the patient suffers from damage to his hip joint and body and also alleges elevated metal ions. After review of medical records patient was revised to address failed left total hip arthroplasty. There was also pain, discomfort, joint instability, walking difficulty, synovitis and foreign body reaction. Revision notes reported that the left metal on metal total hip arthroplasty and developed symptoms of discomfort and instability. Radiographs revealed a vertical acetabular cup and labs revealed elevated metal ions. This was ultimately excised almost entirely along with adjacent reactive synovitis. Revision notes stated that there was a gray nodule protruding through a defect in the iliotibial band. The femoral head component was removed and minimal fretting corrosion at the trunnion of the femoral neck was observed. Removed head, liner and cup. During revision a pseudotumor containing metal debris was removed. Patient experienced pain with activities and metallosis. Doi: (b)(6) 2006. Dor: (b)(6) 2012. (left hip).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09620 |
| MDR Report Key | 9900289 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2012-07-12 |
| Date of Event | 2012-08-15 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2006-08-16 |
| 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 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APEX HOLE ELIM POSITIVE STOP |
| Generic Name | PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT |
| Product Code | LPH |
| Date Received | 2020-03-30 |
| Model Number | 1246-03-000 |
| Catalog Number | 124603000 |
| Lot Number | A2YBD1000 |
| 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 |