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 100 ACET CUP 54MM 1217-01-054 121701054 manufactured by Depuy Orthopaedics Inc Us.
[187728635]
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
[187728636]
Litigation alleges damage to hip joint and body. Update rec? D 04/14/2014 - pfs was received from legal, primary and revision medical records were received from legal, and part/ lot information was identified. Records indicate that the patient was revised because of pain, osteolysis, and corrosion between the stem/head and the stem/ sleeve interfaces. Records are available for further review. The complaint was updated on: 05/12/2014. Update ad 27 jul 2018: in addition to what were previously alleged, ppf alleges metal wear, metallosis and elevated metal ions. After review of medical records, the patient was revised due to painful right metal on metal total hip arthroplasty. Added lawyer, law firm, revision surgeon and hospital. Updated patient initials. Update ad 20 dec 2019. Pfs alleges pain while walking and bending over, inability to do day to day activities, pseudotumors, fluid in the joint, metallosis, necrosis and infection. Medical records report particle disease, swelling, effusion, buttock pain, pseudotumor and discomfort. Lab results indicate that blood chromium and cobalt levels were elevated prior to revision. After further review of medical records, the patient was then revised to address pain and metal reaction. There was clear fluid within the joint, metal corrosion between the femoral head and neck, and between the sleeve and stem. There was also a large amount of osteolysis near the stem. The cup was noted to be under-anteverted by 10-15 degrees. There was no indication of infection. Right hip aspiration on (b)(6) 2012 indicates approximately 10 cc of serosanguineous fluid. Doi: (b)(6) 2002. Dor: (b)(6) 2013; (right hip).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09621 |
| MDR Report Key | 9900275 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2013-08-16 |
| Date of Event | 2013-08-15 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2001-07-30 |
| 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 | PINNACLE 100 ACET CUP 54MM |
| Generic Name | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS |
| Product Code | LPH |
| Date Received | 2020-03-30 |
| Model Number | 1217-01-054 |
| Catalog Number | 121701054 |
| Lot Number | V2CJA1017 |
| 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 |