MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-26 for UNK DEPUY METAL ACETABULAR LINER UNK-HIP manufactured by Depuy International Ltd.8010379.
[46062014]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 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.
Patient Sequence No: 1, Text Type: N, H10
[46062015]
Litigation papers received. Litigation alleges pain and discomfort.
Patient Sequence No: 1, Text Type: D, B5
[48018481]
Conclusion and justification status for mdr: 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
| Report Number | 1818910-2016-20134 |
| MDR Report Key | 5683591 |
| Date Received | 2016-05-26 |
| Date of Report | 2016-05-11 |
| Date Mfgr Received | 2016-06-15 |
| Date Added to Maude | 2016-05-26 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY INTERNATIONAL LTD. 8010379 |
| Manufacturer Street | ST. ANTHONY'S RD |
| 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 | UNK DEPUY METAL ACETABULAR LINER |
| Generic Name | HIP ACETABULAR INSERT/LINER |
| Product Code | KSY |
| Date Received | 2016-05-26 |
| 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 INTERNATIONAL LTD.8010379 |
| Manufacturer Address | ST. ANTHONY'S RD LEEDS LS118 DT UK LS11 8 DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-26 |