FDA Adverse Event
Injury
Summary report: N
UNSPECIFIED KNEE
MDR report key: 129092
·
Received October 29, 1997
Report
- Report Number
- 2219689-1997-00590
- Event Type
- Injury
- Date Received
- October 29, 1997
- Date of Event
- December 5, 1995
- Report Date
- October 28, 1997
- Manufacturer
- HOWMEDICA INC.
- Product Code
- HSH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
SUMMARY OF EVALUATION: EVALUATION COULD NOT BE PERFORMED. DEVICE NOT RETURNED TO HOWMEDICA RUTHERFORD.
Description of Event or Problem · 1
RPTR STATES, "ON SEPTEMBER 9, 1995, PT PRESENTED WITH COMPLAINTS OF SEVERE PAIN AND SWELLING, ORIGINATING AT THE LEFT KNEE PROSTHESIS. ON SEPTEMBER 19, 1995, LEFT KNEE ASPIRATION WAS DONE, ALONG WITH X-RAYS. X-RAYS, REVEALED THE KNEE PROSTHESIS HAD SHATTERED. ON DECEMBER 27, 1995, THE PT WAS ADMITTED TO THE HOSP WITH DIAGNOSIS MYCOBACTERIUM CHELONAE ABSCESSUS OF THE LEFT KNEE. THE PROSTHESIS WAS EXPLANTED AND FUSION OF THE LEFT KNEE WAS PERFORMED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNSPECIFIED KNEE Implant | IMPLANT | HSH | HOWMEDICA INC. | NA | TDSKA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |