MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for LATERAL ASSEMBLY, RADIAL STEM IMPLANT, SIZE 4 3100003 manufactured by Stryker Gmbh.
[130311358]
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device was not received.
Patient Sequence No: 1, Text Type: N, H10
[130311359]
Patient was lifting a box overhead, lateral radial head dislodged from stem. Both head and stem implants were explanted. Competitive product used as replacement.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 0008031020-2018-01057 |
MDR Report Key | 8162197 |
Date Received | 2018-12-13 |
Date of Report | 2019-02-21 |
Date of Event | 2018-11-15 |
Date Mfgr Received | 2019-01-24 |
Device Manufacturer Date | 2014-12-23 |
Date Added to Maude | 2018-12-13 |
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. ANNA JUSINSKI |
Manufacturer Street | 325 CORPORATE DRIVE |
Manufacturer City | MAHWAH NJ 07430 |
Manufacturer Country | US |
Manufacturer Postal | 07430 |
Manufacturer Phone | 2018315000 |
Manufacturer G1 | STRYKER GMBH |
Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
Manufacturer City | SELZACH 2545 |
Manufacturer Country | CH |
Manufacturer Postal Code | 2545 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | LATERAL ASSEMBLY, RADIAL STEM IMPLANT, SIZE 4 |
Generic Name | ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS |
Product Code | JDB |
Date Received | 2018-12-13 |
Catalog Number | 3100003 |
Lot Number | 10187-L04 |
Device Expiration Date | 2019-12-31 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | STRYKER GMBH |
Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2018-12-13 |