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 2016-09-16 for BIOSTOP G CEM RESTR 10MM 546310000 manufactured by Depuy Cmw 9610921.
[54934200]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. Udi: ((b)(4). 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
[54934201]
It was reported that during an endoprosthesis hip surgery when inserting the plug in the femoral canal, with the help of the proper instruments, it broke off. The broken piece was retrieved.
Patient Sequence No: 1, Text Type: D, B5
[57641040]
The complaint states that during hip surgery, the biostop restrictor broke off despite the use of the proper instrumentation and had to be removed from the patient and replaced. As the product is not available for return, no photographs have been supplied and the product is manufactured externally, the investigation is limited as the product cannot be tested to assess if it works and/or to detect the fault. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2016-27370 |
| MDR Report Key | 5955986 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-09-16 |
| Date of Report | 2016-08-29 |
| Date of Event | 2016-08-29 |
| Date Mfgr Received | 2016-10-14 |
| Date Added to Maude | 2016-09-16 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY CMW 9610921 |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL, LANCASHIRE FY4 4QQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | FY4 4QQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSTOP G CEM RESTR 10MM |
| Generic Name | CEMENT / CEMENT ACCESSORY |
| Product Code | JDK |
| Date Received | 2016-09-16 |
| Catalog Number | 546310000 |
| Lot Number | 15I2203013 |
| Device Expiration Date | 2018-09-30 |
| 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 CMW 9610921 |
| Manufacturer Address | CORNFORD RD BLACKPOOL, LANCASHIRE FY4 4QQ UK FY4 4QQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-16 |