MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-06 for PINNACLE SECTOR II CUP 54MM 1217-22-054 121722054 manufactured by Depuy Orthopaedics Inc Us.
[183264924]
Product complaint # (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
[183264925]
It was reported the patient was with right femoral head ischemic necrosis and had a right total hip arthroplasty and hip arthrolysis on (b)(6) 2018. On (b)(6) 2019, the patient noted the wound exuded fluid. The patient was in hospital on (b)(6) 2019 and had an anti-infective treatment with broad-spectrum antibiotics and regular disinfection. Doi: (b)(6) 2018. The patient was implanted with pinnacle cup to treat ischemic necrosis of the right femoral head. Date of incident: (b)(6) 2019. The patient was re-admitted to the hospital and reported oozing wound exudate. The surgeon diagnosed poor wound healing and a postoperative wound infection. The patient was treated with parenteral and oral antibiotics, as well as daily manual wound disinfection and dressing changes. The wound was fully healed on (b)(6) 2020 with no indication of infection. No revision was performed, and no product defects were reported. Doi: (b)(6) 2019, date of incident: (b)(6) 2019, right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07138 |
| MDR Report Key | 9801763 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-06 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-02-04 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2018-04-10 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 SECTOR II CUP 54MM |
| Generic Name | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS |
| Product Code | MRA |
| Date Received | 2020-03-06 |
| Model Number | 1217-22-054 |
| Catalog Number | 121722054 |
| Lot Number | 8770073 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-06 |