MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-07-19 for LATITUDE ELBOW PROSTHESIS manufactured by Tornier Inc..
[114494255]
This is the final report submitted regarding this surgical event and medical device. Literature reference: hemiarthroplasty for the treatment of distal humeral fractures: midterm clinical results. Mark schultzel, md, karl scheidt, md, christopher c. Klein, bs, steven j. Narvy, md, brian k. Lee, md; john m. Itamura, md journal of shoulder and elbow surgery 2017, vol. 26, 389-393. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[114494256]
It was reported in the literature (schultzel et al. 2017), of the 10 patients implanted with latitude there were 2 complications reported. One was for an intra-operative fracture that was treated with plate fixation and one complaint was for prominent olecranon hardware which required surgical removal at 1 year post-op. No further patient complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004983210-2018-00033 |
| MDR Report Key | 7704292 |
| Report Source | LITERATURE |
| Date Received | 2018-07-19 |
| Date of Report | 2018-07-19 |
| Date Mfgr Received | 2018-06-20 |
| Date Added to Maude | 2018-07-19 |
| 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 | MR. MATT KENNEDY |
| Manufacturer Street | 10801 NESBITT AVE S |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9526837482 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATITUDE ELBOW PROSTHESIS |
| Generic Name | ELBOW PROSTHESIS |
| Product Code | JDB |
| Date Received | 2018-07-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC. |
| Manufacturer Address | 10801 NESBITT AVENUE S BLOOMINGTON MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-19 |