MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-08-16 for SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, L N/A 01.04555.120 manufactured by Zimmer Gmbh.
[154527398]
Concomitant medical products: name: humeral head 40-14, item#: 0104555400, lot#: 2716925. Name: a. S. Glenoid s cemented, item#: 0104214340, lot#: 2824234. Surgical reports were received and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. The lot number of the device was received. The device history records will be reviewed during investigation. An e-mail requesting the following additional information was sent on august 16, 2019 to the appropriate representatives. The availability of the affected product(s) (non-availability with a rationale) all available x-rays during time in- vivo with printed date were there any contributing conditions related to the event? (ex: trauma, illness, related non-compliance, patient anatomy) was the surgical technique for the product utilized? 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
[154527399]
It was reported that the patient was revised due to loosening with possible migration of the sidus anchor in the bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2019-00501 |
| MDR Report Key | 8900451 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-08-16 |
| Date of Report | 2019-09-18 |
| Date of Event | 2018-06-18 |
| Date Mfgr Received | 2019-08-29 |
| Device Manufacturer Date | 2015-11-04 |
| Date Added to Maude | 2019-08-16 |
| 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, L |
| Generic Name | SIDUS STEM-FREE SHOULDER |
| Product Code | PKC |
| Date Received | 2019-08-16 |
| Model Number | N/A |
| Catalog Number | 01.04555.120 |
| Lot Number | 2833839 |
| 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 | 2019-08-16 |