FDA Adverse Event
Injury
Summary report: N
UNKNOWN ADM/MDM INSERT
MDR report key: 8025171
·
Received October 31, 2018
Report
- Report Number
- 0002249697-2018-03560
- Event Type
- Injury
- Date Received
- October 31, 2018
- Date of Event
- August 23, 2018
- Report Date
- October 31, 2018
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
RECEIVED EMAIL NOTIFICATION OF POLY EXCHANGE OF HIP THAT OCCURRED ON (B)(6) 2018. UPDATE 05/OCTOBER/2018: AS REPORTED IN HOW WAS ISSUE NOTICED: "DOCTOR PLANNED ROUTINE POLY EXCHANGE OF HIP. INTRAOPERATIVELY NOTICED IMPINGEMENT OF STEM. MADE DECISION TO REVISE STEM AND POLY EXCHANGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 864542 | UNKNOWN ADM/MDM INSERT | HIP IMPLANT | JDI | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization| R |