MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-05 for SROM STM STD 36+12L 13X18 56-3618 563618 manufactured by Depuy Orthopaedics Inc Us.
[187547191]
(b)(4). Initial reporter occupation: lawyer. 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
[187547192]
After review of medical records, the patient was revised to address metallosis, pain, elevated metal ion levels and osteolysis. Intraoperatively, tan appearing synovial fluid consistent with metallosis was obtained. Discharge summary notes history of swelling and marked loss of function. Doi: (b)(6) 2009; dor: (b)(6) 2017 (left hip).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07014 |
| MDR Report Key | 9794638 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-05 |
| Date of Report | 2020-02-18 |
| Date of Event | 2017-04-26 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2009-05-29 |
| Date Added to Maude | 2020-03-05 |
| 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 IRELAND - 9616671 |
| Manufacturer Street | LOUGHBEG RINGASKIDDY CO. |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SROM STM STD 36+12L 13X18 |
| Generic Name | S-ROM HIP SYSTEM : HIP FEMORAL STEM |
| Product Code | MRA |
| Date Received | 2020-03-05 |
| Model Number | 56-3618 |
| Catalog Number | 563618 |
| Lot Number | 2932974 |
| Device Expiration Date | 2014-05-31 |
| 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 | 2020-03-05 |