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 2020-03-27 for HUMERUS GSB-III 76 N/A 00000000536 manufactured by Zimmer Gmbh.
[186090776]
Medical products and therapy date detail of product: item #: 00000000511, item name: bushing of moving part 76/86, lot #: unknown. Item #: 00000000571, item name: gsb iii ulna 12/61, lot #: 2566460. The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. The device history records were reviewed and found to be conforming. Attempts to obtain additional information have been made; however, no more is available. 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
[186090777]
It was reported that patient underwent revision surgery several days after a trauma incident (fall), whereby the humerus fractured. Post revision surgery, the surgeon found that the implant gave resistance during extension-flexion testing on the prep table. The surgeon doesn't know if the patient experienced problems flexing or extending the arm when the device was implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2020-00154 |
| MDR Report Key | 9887910 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2011-11-18 |
| Date Added to Maude | 2020-03-27 |
| 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 | HUMERUS GSB-III 76 |
| Generic Name | PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED |
| Product Code | JDC |
| Date Received | 2020-03-27 |
| Model Number | N/A |
| Catalog Number | 00000000536 |
| Lot Number | 2630268 |
| Device Expiration Date | 2016-10-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2020-03-27 |