TORNIER PERFORM ANATOMIC AUG MED RIGHT GLENOID 15 DG
Report
- Report Number
- 0001649390-2024-00105
- Event Type
- Injury
- Date Received
- March 8, 2024
- Date of Event
- February 7, 2024
- Report Date
- April 11, 2024
- Manufacturer
- TORNIER INC
- Product Code
- KWS
- UDI-DI
- 00846832089048
- PMA / PMN Number
- K150583
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CORRECTION: D4 CATALOG #, D1(PRODUCT LONG DESCRIPTION), D4 GTIN. THE REPORTED EVENT WAS NOT CONFIRMED, BASED ON THE AVAILABLE X-RAY AND MEDICAL EXPERT OPINION. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE X-RAYS BY THE MEDICAL EXPERT STATED; ¿THE ALLEGED FAILURE RELATES TO SENSORY LOSS IN THE AREA OF THE MEDIAN NERVE. SINCE THE DEVICE IS INTACT, THERE IS NO DEVICE RELATED PROBLEM. SINCE NO TIMELINE IS GIVEN, AND THERE IS NO MENTIONING OF MOTOR-LOSS, THIS EVENT DOES NOT NECESSARILY HAS TO BE RELATED TO THE PROCEDURE. (I.E., CARPAL TUNNEL SYNDROME AT THE LEVEL OF THE WRIST). IN ORDER TO DETERMINE REASON BEHIND THE ALLEGED FAILURE A MORE DETAILED INFORMATION ON TIMELINE WOULD BE REQUIRED.¿ THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED, AND THE LOT NUMBER WAS NOT COMMUNICATED. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE EXACT ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.
THIS DEVICE WAS NOT CLEARED IN THE US; HOWEVER, A SIMILAR DEVICE WAS CLEARED UNDER 510K # K150583. THE REPORTED EVENT WAS NOT CONFIRMED, BASED ON THE AVAILABLE X-RAY AND MEDICAL EXPERT OPINION. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE X-RAYS BY THE MEDICAL EXPERT STATED; ¿THE ALLEGED FAILURE RELATES TO SENSORY LOSS IN THE AREA OF THE MEDIAN NERVE. SINCE THE DEVICE IS INTACT, THERE IS NO DEVICE RELATED PROBLEM. SINCE NO TIMELINE IS GIVEN, AND THERE IS NO MENTIONING OF MOTOR-LOSS, THIS EVENT DOES NOT NECESSARILY HAS TO BE RELATED TO THE PROCEDURE. (I.E., CARPAL TUNNEL SYNDROME AT THE LEVEL OF THE WRIST). IN ORDER TO DETERMINE REASON BEHIND THE ALLEGED FAILURE A MORE DETAILED INFORMATION ON TIMELINE WOULD BE REQUIRED.¿ THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED, AND THE LOT NUMBER WAS NOT COMMUNICATED. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE EXACT ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. H3 OTHER TEXT : DEVICE DISPOSITION UNKNOWN.
SUBJECT REPORTS EXPERIENCING NUMBNESS IN FINGERS, ACCOMPANIED BY DECREASED SENSATION AND WEAKNESS IN THE THUMB, INDEX, AND MIDDLE FINGERS.
SUBJECT REPORTS EXPERIENCING NUMBNESS IN FINGERS, ACCOMPANIED BY DECREASED SENSATION AND WEAKNESS IN THE THUMB, INDEX, AND MIDDLE FINGERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159186 | TORNIER PERFORM ANATOMIC AUG MED RIGHT GLENOID 15 DG | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | KWS | TORNIER INC | UNKNOWN | 00846832089048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Other |