MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-06-11 for BIOSTOP G CEM RESTR 12MM 546312000 manufactured by Depuy Cmw 9610921.
[20438947]
First stage reverse shoulder revision due to infection.
Patient Sequence No: 1, Text Type: D, B5
[20693298]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[23162040]
The devices associated to the complaint were returned for analysis. The dhr analysis performed did not reveal any anomalies that could be related to the issue reported on the complaint. A search into the complaints database was performed, one other similar complaint was reported for the affected batch (b)(4). The sterile certificates were reviewed for the provided product codes and lots combinations, no anomaly was detected. Based on the information received and the investigation performed, the root cause of the incident could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2015-23295 |
| MDR Report Key | 4838163 |
| Report Source | 01,05 |
| Date Received | 2015-06-11 |
| Date of Report | 2015-06-02 |
| Date of Event | 2015-06-02 |
| Date Mfgr Received | 2015-07-30 |
| Date Added to Maude | 2015-06-11 |
| 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 CMW 9610921 |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL FY44QQ |
| 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 12MM |
| Generic Name | CEMENT / CEMENT ACCESSORY |
| Product Code | JDK |
| Date Received | 2015-06-11 |
| Catalog Number | 546312000 |
| Lot Number | 14L1501 |
| Operator | PHYSICIAN |
| 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 FY44QQ UK FY4 4QQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-11 |