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 2018-10-19 for SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, S N/A 01.04555.110 manufactured by Zimmer Gmbh.
[124290789]
Concomitant medical product: sidus extremities impl win gen; part# unknown; lot# unknown. Therapy date: (b)(6) 2017. The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. 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).
Patient Sequence No: 1, Text Type: N, H10
[124290790]
Patient was implanted on an unknown side and underwent revision surgery as the implant was not working as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-01084 |
| MDR Report Key | 7982875 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2018-10-19 |
| Date of Report | 2018-12-06 |
| Date of Event | 2017-12-27 |
| Date Mfgr Received | 2018-11-16 |
| Device Manufacturer Date | 2012-03-20 |
| Date Added to Maude | 2018-10-19 |
| 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 | 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 ANCHOR, UNCEMENTED, S |
| Generic Name | SIDUS EXTREMITIES IMPL WIN GEN |
| Product Code | PKC |
| Date Received | 2018-10-19 |
| Model Number | N/A |
| Catalog Number | 01.04555.110 |
| Lot Number | 2643707 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-10-19 |