MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-09-02 for BIOSTOP G CEM RESTR 12MM 546312000 manufactured by Depuy Orthopaedics, Inc. 1818910.
[4906136]
Revision: shoulder arthroplasty performed on (b)(6) 2014 at (b)(6). Reason: glenoid prosthesis loosening. Primary: performed in (b)(6) 2004 at (b)(6). Explants - pegged glenoid prosthesis, further info tba. Implants; glenoid head - 113787025 lot 148841? , excentric head 52 x 21 -112852120 lot d13120041? Pt details: (b)(6) yrs. Photos, reports available. (b)(6) 2014 - email received from (b)(6) conforming the following additional information from the surgeon - the surgeon did indicate during the case that as the glenoid and humeral head showed no signs of wear, reason for the revision was a case of cement failure as opposed to implant failure. Cement confirmed as depuy cement.
Patient Sequence No: 1, Text Type: D, B5
[12280613]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[22711015]
Additional narrative:this product was originally reported in error. Depuy considers the investigation closed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2014-26978 |
| MDR Report Key | 4050842 |
| Report Source | 01,05 |
| Date Received | 2014-09-02 |
| Date of Report | 2014-08-19 |
| Date of Event | 2014-08-19 |
| Date Mfgr Received | 2014-11-21 |
| Date Added to Maude | 2014-09-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE DOWELL |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743714918 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSTOP G CEM RESTR 12MM |
| Generic Name | CEMENT / CEMENT ACCESSORY |
| Product Code | JDK |
| Date Received | 2014-09-02 |
| Catalog Number | 546312000 |
| Lot Number | 03A2801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-02 |