MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2018-05-08 for SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 52-19 N/A 01.04555.520 manufactured by Zimmer Gmbh.
[107564288]
Device is not expected, but investigation is in progress: the device will not be returned for analysis as it is still implanted; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. The device history records were reviewed and found to be conforming. Surgical reports were received and will be reviewed as part of ongoing investigation. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. (b)(4). The following report is associated with this event: 0009613350-2018-00496.
Patient Sequence No: 1, Text Type: N, H10
[107564289]
It was reported that the patient experiences progressive glenoid radiolucency and is being monitored. Attempts to obtain additional information have been made; however, no more is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-00493 |
| MDR Report Key | 7493501 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2018-05-08 |
| Date of Report | 2018-10-02 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2018-09-28 |
| Device Manufacturer Date | 2015-09-22 |
| Date Added to Maude | 2018-05-08 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER GMBH |
| Manufacturer Street | SULZER ALLEE 8 SULZER INDUSTRIE PARK |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 52-19 |
| Generic Name | SIDUS STEM-FREE SHOULDER |
| Product Code | PKC |
| Date Received | 2018-05-08 |
| Model Number | N/A |
| Catalog Number | 01.04555.520 |
| Lot Number | 2829244 |
| ID Number | 00889024415997 |
| 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 | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-08 |