MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-11 for SROM STM STD 36+12L 15X20 56-3620 563620 manufactured by Depuy Orthopaedics Inc Us.
[182956757]
(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
[182956758]
Medical records received. After review of medical records, there was no revision reported. The patient was unable to undergo revision and is now deceased. Date of death or reason of death was not provided. Clinic visit on (b)(6) 2011 notes that the patient reports persistent pain and discomfort. Past workup indicates fluid and irregularity on the patient's recent mr scan. Clinic visit on (b)(6) 2011 indicates immobility and elevated cobalt level at 23. 2 ng/ml (23. 2 ug/l). Primary surgery notes indicate that the sleeve was left slightly proud upon impaction. Doi: (b)(6) 2007, dor: not revised (left hip).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07453 |
| MDR Report Key | 9818225 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2006-11-06 |
| Date Added to Maude | 2020-03-11 |
| 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 DR. |
| 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 15X20 |
| Generic Name | S-ROM HIP SYSTEM : HIP FEMORAL STEM |
| Product Code | MRA |
| Date Received | 2020-03-11 |
| Model Number | 56-3620 |
| Catalog Number | 563620 |
| Lot Number | 2254343 |
| Device Expiration Date | 2011-10-31 |
| 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 | 2020-03-11 |