FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 2930038
·
Received January 25, 2013
Report
- Report Number
- 0002249697-2013-00292
- Event Type
- Injury
- Date Received
- January 25, 2013
- Date of Event
- October 9, 2012
- Report Date
- January 10, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER RIGHT KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE EVALUATED BY MFR: NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 1
THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PAIN INVOLVING A UNKNOWN STRYKER KNEE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION PROVIDED. PATIENT MEDICAL RECORDS WOULD BE NEEDED TO FURTHER EVALUATE THE REPORTED PAIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCES PAIN WHEN WALKING AND LYING DOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCES PAIN WHEN WALKING AND LYING DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35249 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMLANT | JWH | STRYKER ORTHOPAEDICS-MAHWAH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |