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 2017-08-31 for UNKNOWN SROM STEM 100MM UNK-HIP manufactured by Depuy Orthopaedics, Inc. 1818910.
[84090740]
Complete product detail has not been received at this time. If further information is received a follow-up medwatch will be filed as appropriate. 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
[84090741]
The patient was revised to address stem or sleeve junction fracture. Reinforcement pin in poly fracture. It was also stated that there was a loosening at the bone to cement interface. Unknown cement was used.
Patient Sequence No: 1, Text Type: D, B5
[106996042]
No device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. The investigation could not draw any conclusions regarding the reported event. Depuy considers the investigation closed at this time. Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. 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
[106996043]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2017-23804 |
| MDR Report Key | 6833627 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-31 |
| Date of Report | 2017-08-01 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-12-14 |
| Date Added to Maude | 2017-08-31 |
| 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 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 | UNKNOWN SROM STEM 100MM |
| Generic Name | LPS IMPLANT |
| Product Code | OVO |
| Date Received | 2017-08-31 |
| Catalog Number | UNK-HIP |
| Lot Number | UNKNOWN |
| 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 | 2017-08-31 |