MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-26 for GSOURCE 11.5" SHAFT 50MM HEAD Z1302 1301 manufactured by Gsource.
[30222908]
A (b)(6) male, on (b)(6) 2015, underwent reimplantation of right total hip replacement (s/p removal of right total hip replacement with insertion of antibiotic spacer on (b)(6) 2015 for infected right total hip replacement). Intra-operatively, on (b)(6) 2015, after removing the spacer head, it was noted that there was a round black disk within the cotyloid fossa. The disk was removed. The procedure was completed. The patient was discharged home with home care services on (b)(6) 2015. It was subsequently learned that the black disk was a small portion from the top of the cup pusher that was used during spacer placement and right total hip replacement removal on (b)(6) 2015. Apparently, a small portion of the instrument broke off and was retained. Due to its location, the portion of the disk wasn't visible on post-operative x-rays following the (b)(6) 2015 surgery. The post-operative course following the (b)(6) 2015 spacer surgery had been uneventful. Mfr#: 2249529-2015-00001.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5179829 |
| MDR Report Key | 5179829 |
| Date Received | 2015-10-26 |
| Date of Report | 2015-07-20 |
| Date of Event | 2015-07-06 |
| Date Facility Aware | 2015-07-06 |
| Report Date | 2015-07-20 |
| Date Reported to Mfgr | 2015-07-20 |
| Date Added to Maude | 2015-10-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GSOURCE |
| Generic Name | CUP PUSHER - BLACK DELRIN HEAD |
| Product Code | HXO |
| Date Received | 2015-10-26 |
| Returned To Mfg | 2015-07-20 |
| Model Number | 11.5" SHAFT 50MM HEAD |
| Catalog Number | Z1302 1301 |
| Lot Number | 336 1304 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GSOURCE |
| Manufacturer Address | EMERSON NJ 07630 US 07630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-10-26 |