FDA Adverse Event
Injury
Summary report: N
UNKNOWN RIGHT TOTAL KNEE REPLACEMENT
MDR report key: 2071010
·
Received April 20, 2011
Report
- Report Number
- 2249697-2011-00547
- Event Type
- Injury
- Date Received
- April 20, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 29, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SWELLING OF THE KNEE, REDNESS, CONSTANTLY IN PAIN. SHE TRIPS ON EVERYTHING. HER KNEE DOESN'T BEND LIKE IT USED TO. THE PAIN IS ALSO AFFECTION HER BACK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN RIGHT TOTAL KNEE REPLACEMENT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |