MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-19 for SUMMIT POR TAPER SZ2 STD OFF 1570-01-080 157001080 manufactured by Depuy Orthopaedics Inc Us.
[184059652]
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
[184059653]
Pinnacle claim submission form and medical records received. After review of medical records, the patient was revised to address pain and periprosthetic infection. Aspiration was negative for bacteria but also had 111 white blood cells. Intraoperatively, there was gross pus, bone loss, a deficiency of the posterior column related to the infection and fracture cracks in the proximal femur. Implants were removed and a non-articulating spacer construct of unknown manufacturer was placed. Revision notes on the second revision for removal of said spacer on (b)(6) 2018 indicate presence of a dark murky fluid consistent with metallosis as well as chalky, metallosis type debris. Doi: (b)(6) 2006, dor: (b)(6) 2018 (right hip).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-08565 |
| MDR Report Key | 9852875 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-02 |
| Date of Event | 2018-04-17 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2004-11-10 |
| Date Added to Maude | 2020-03-19 |
| 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 DR. |
| 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 | SUMMIT POR TAPER SZ2 STD OFF |
| Generic Name | SUMMIT HIP STEM : HIP FEMORAL STEM |
| Product Code | MRA |
| Date Received | 2020-03-19 |
| Model Number | 1570-01-080 |
| Catalog Number | 157001080 |
| Lot Number | Y5XEH1000 |
| 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 | 2020-03-19 |