MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-10-09 for UNKNOWN DEPUY FEMORAL HEAD UNK-HIP manufactured by Depuy International Ltd. 8010379.
[27983393]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time. 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
[27983394]
Litigation alleges patient suffers from pain.
Patient Sequence No: 1, Text Type: D, B5
[30212349]
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. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. Depuy considers the investigation closed at this time. 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
[101842723]
Udi: (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[101842724]
Update jul 05, 2017: pfs and medical records received. Pfs alleges metal poisoning, fatigue and limited movement. After review of medical records for mdr reportability it was reported that the patient was revised to address increased metal ions. It was reported on the operative notes that there were no metallosis staining of the soft tissue. No pseudotumors encountered. The femoral stem was in good anteversion and was found to be well-fixed as well as the acetabular component. No report of corrosion. Laboratory result for cobalt is above 7ppb. Updated the part/lot information and added the femoral stem. This complaint was updated on: jul 13, 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2015-32513 |
| MDR Report Key | 5142027 |
| Report Source | OTHER |
| Date Received | 2015-10-09 |
| Date of Report | 2017-07-05 |
| Date of Event | 2015-07-09 |
| Date Mfgr Received | 2018-07-16 |
| Device Manufacturer Date | 2010-05-21 |
| Date Added to Maude | 2015-10-09 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | LEEDS MFG & MATERIAL WAREHOUSE |
| Manufacturer Street | ST ANTHONYS ROAD |
| Manufacturer City | LEEDS LS118 DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8 DT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DEPUY FEMORAL HEAD |
| Generic Name | HIP FEMORAL HEAD |
| Product Code | HSA |
| Date Received | 2015-10-09 |
| Catalog Number | UNK-HIP |
| Lot Number | UNK |
| 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 INTERNATIONAL LTD. 8010379 |
| Manufacturer Address | ST. ANTHONY'S RD LEEDS LS118 DT UK LS11 8 DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-09 |