MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-21 for BIOSTOP G CEM RESTR 12MM 546312000 manufactured by Depuy Orthopaedics, Inc. 1818910.
[136729771]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device was used for treatment, not diagnosis. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[136729772]
It was reported that patient presented with hip pain and instability. Ct revealed some osteolysis behind cup. Initial plan was to remove cup and assess damage. Upon dislocation, found stem was loose. Stem was removed easily by hand. Opted to put in reclaim revision stem and swap out the liner in the cup to a duraloc constrained. Cup was left in due to solid fixation. The loosening was at bone to cement interface. Doi: unknown; dor: (b)(6) 2019, right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-85285 |
| MDR Report Key | 8357433 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-21 |
| Date of Report | 2019-01-31 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-03-01 |
| Device Manufacturer Date | 1998-11-19 |
| Date Added to Maude | 2019-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY CMW |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL IN 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 12MM |
| Generic Name | DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG |
| Product Code | JDK |
| Date Received | 2019-02-21 |
| Catalog Number | 546312000 |
| Lot Number | S58GM1000 |
| 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 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-21 |