MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-12-05 for UNKNOWN DEPUY CATHCART TAPERED SPACER UNK-HIP manufactured by 1818910 Depuy Orthopaedics, Inc..
[4046095]
Revision due to infection.
Patient Sequence No: 1, Text Type: D, B5
[11326061]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[19277361]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Revision due to infection. Doi unk; dor (b)(6) 2013 (right hip). The devices associated with this report were not returned. Review of the device history records and/or a lot specific complaint database search was not possible as the lot codes required were not provided. Requests for additional investigational inputs were made in accordance with wi-7915 appendix a. No additional information was obtained. The investigation could not verify or identify any product contribution to the reported event with the information provided. Based on the inability to identify root cause, the need for corrective action was not indicated. Depuy considers the investigation closed. 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 | 1818910-2013-35204 |
| MDR Report Key | 3501626 |
| Report Source | 05,08 |
| Date Received | 2013-12-05 |
| Date of Report | 2013-11-13 |
| Date of Event | 2013-11-13 |
| Date Mfgr Received | 2014-01-27 |
| Date Added to Maude | 2013-12-05 |
| 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 | STACEY TRICK |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743714554 |
| Manufacturer G1 | 1818910 DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DEPUY CATHCART TAPERED SPACER |
| Generic Name | SPACER |
| Product Code | LTO |
| Date Received | 2013-12-05 |
| 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 | 1818910 DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-05 |