MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-24 for LATERAL ASSEMBLY, RADIAL IMPLANT, SIZE 1 3100000 manufactured by Stryker Gmbh.
[124949833]
Due to the ongoing litigation no additional information is available at this time. If additional information is received it will be reported on a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[124949834]
It? S alleged by the attorney, through the filing of a legal claim, that the patient had a stryker lateral head and stem elbow implanted on or about (b)(6) 2016. It is further alleged that after his elbow replacement, he began to experience increasing pain and decreased function. He then visited his orthopedic doctor who confirmed loosening of the radial head components and recommended immediate revision surgery, which took place on or about (b)(6) 2016. Within one week of his revision surgery, the claimant had to undergo re-revision of the radial head component on or about (b)(6) 2016 due to the component coming loose and dislodging for a second time. This pi is for revision 1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2018-00891 |
| MDR Report Key | 8002759 |
| Date Received | 2018-10-24 |
| Date of Report | 2018-12-12 |
| Date of Event | 2016-10-13 |
| Date Mfgr Received | 2018-11-14 |
| Device Manufacturer Date | 2015-11-24 |
| Date Added to Maude | 2018-10-24 |
| 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 IMPLANT, SIZE 1 |
| Generic Name | ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS |
| Product Code | JDB |
| Date Received | 2018-10-24 |
| Catalog Number | 3100000 |
| Lot Number | 24880201 |
| 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 | 2018-10-24 |