FDA Adverse Event
Injury
Summary report: N
HYLAMER NEUT 48OD X 28ID
MDR report key: 1192014
·
Received October 6, 2008
Report
- Report Number
- 1818910-2008-04337
- Event Type
- Injury
- Date Received
- October 6, 2008
- Date of Event
- September 11, 2008
- Report Date
- September 11, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWY
- PMA / PMN Number
- K940743
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION IN 1995. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
THE PATIENT WAS REVISED BECAUSE OF POLY WEAR AND OSTEOLYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYLAMER NEUT 48OD X 28ID | 87KWY | KWY | DEPUY ORTHOPAEDICS, INC. | NA | 880910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |