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 PINNACLE 300 ACET CUP 50MM 1217-03-050 121703050 manufactured by Depuy Orthopaedics Inc Us.
[186722366]
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
[186722367]
Litigation alleges that patient experienced pain, weakness, difficulty with simple daily living activities, inability to return to work, and increased metallic ions in his bloodstream. Revision operative note reviewed and confirmed metallosis. The revision operative note also mentions alval. In addition to what previously alleged, litigation alleged metal wear, skin rashes, weight loss, pain, increase incidence of atrial fibrillation, anxiety, thirst, loose of taste, metallic taste in saliva, and dry fragile skin. After review of medical records it was indicated that the patient present with progressive worsening left hip pain, demonstrated elevated metal ions. The patient was then revised for painful metal-sensitivity reaction to necrosis (alval). Operative notes reported that the cup was little generously anteverted and there was some erosive deficiency noted of the anterior acetabular bony wall, due to inflammatory process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09610 |
| MDR Report Key | 9899671 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2012-05-23 |
| Date of Event | 2011-03-16 |
| Date Mfgr Received | 2020-03-15 |
| Device Manufacturer Date | 2009-02-27 |
| 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 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 | PINNACLE 300 ACET CUP 50MM |
| Generic Name | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS |
| Product Code | LPH |
| Date Received | 2020-03-30 |
| Model Number | 1217-03-050 |
| Catalog Number | 121703050 |
| Lot Number | DG4F21000 |
| 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 |