FDA Adverse Event
Injury
Summary report: N
DELTA V-40 CERAMIC HEAD 32/-4
MDR report key: 3961943
·
Received July 28, 2014
Report
- Report Number
- 0002249697-2014-02882
- Event Type
- Injury
- Date Received
- July 28, 2014
- Date of Event
- July 8, 2014
- Report Date
- July 8, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LZO
- PMA / PMN Number
- K052718
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.
Additional Manufacturer Narrative · 1
AN EVENT REGARDING MALPOSITION INVOLVING A TRITANIUM SHELL ((B)(4)) WAS REPORTED. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT HIP DUE TO ILIOPSOAS TENDON IMPINGEMENT.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT HIP DUE TO ILIOPSOAS TENDON IMPINGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 437709 | DELTA V-40 CERAMIC HEAD 32/-4 | IMPLANT | LZO | STRYKER ORTHOPAEDICS-MAHWAH | 38763803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |