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..
[114457510]
This is the final report submitted regarding this surgical event and medical device. Literature reference: hemiarthroplasty of the distal humerus for acute and chronic complex intra-articular injuries. Donald w. Hohman, md, scott r. Nodzo, md, lars m. Qvick, md, thomas r. Duquin, md, paul p. Paterson, md; journal of shoulder and elbow surgery 2014, vol. 23, 265-272.
Patient Sequence No: 1, Text Type: N, H10
[114457511]
It was reported in the literature (hohman, donald et al. 2014), there were 5 complications in 5 patients implanted with the latitude prothesis. One patient sustained an intraoperative fracture of the humeral diaphysis, which underwent reduction with fixation at the time of surgery, and healed uneventfully with no apparent effect on outcome. Four patients required 1 or more subsequent surgical procedures; however, there were no component revisions or conversions to total elbow arthroplasty. Three patients required removal of prominent supplementary instrumentation used for fixation, one of which was for kirschner wires, one for the supplementary suture button device, and one from the olecranon osteotomy fixation. In the fourth patient, a postoperative ulnar neuropathy developed and ulnar nerve transposition was required 8 months postoperatively. No further patient complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004983210-2018-00032 |
| MDR Report Key | 7703035 |
| 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 |