MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-01 for INBONE? 200012902 manufactured by Wright Medical Technology, Inc..
[69016608]
The device was not returned for evaluation; however films were supplied for review. Analysis results are not available at the time of this report. A follow-up report will be sent when the analysis is complete. Associated with reports 1043534-2017-00025 and 1043534-2017-00026.
Patient Sequence No: 1, Text Type: N, H10
[69016609]
Allegedly, it was reported that the patient underwent an ankle surgical procedure. Approximately 8 months post-op, it was found that the tibial stem implants are disassociated or broken. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2017-00024 |
| MDR Report Key | 6368320 |
| Date Received | 2017-03-01 |
| Date of Report | 2017-02-06 |
| Date of Event | 2017-02-06 |
| Date Facility Aware | 2017-02-06 |
| Date Mfgr Received | 2017-02-06 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2017-03-01 |
| 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 | TIMOTHY NICKEL |
| Manufacturer Street | 1023 CHERRY ROAD |
| Manufacturer City | 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer Phone | 901451-631 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
| Manufacturer City | 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INBONE? |
| Generic Name | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Product Code | HSA |
| Date Received | 2017-03-01 |
| Returned To Mfg | 2017-06-07 |
| Model Number | 200012902 |
| Lot Number | 1538367 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 11576 MEMPHIS ARLINGTON RD 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-01 |