FDA Adverse Event
Injury
Summary report: N
ENDO MODEL MODULAR KNEE PROTHESIS SYSTEM
MDR report key: 17548376
·
Received August 15, 2023
Report
- Report Number
- 3004371426-2023-00077
- Event Type
- Injury
- Date Received
- August 15, 2023
- Date of Event
- April 27, 2023
- Report Date
- July 18, 2023
- Manufacturer
- WALDEMAR LINK GMBH & CO.KG
- Product Code
- KRO
- PMA / PMN Number
- K211768
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE.
Additional Manufacturer Narrative · 0
THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE.
Description of Event or Problem · 0
SURGEON INDICATES THAT THE PATIENT NEEDS FEMORAL-SIDE REVISION DUE TO PAIN AND AUDIBLE CLICKING THAT SURGEON BELIEVES IS RELATED TO MOVEMENT AT THE UHMWPE FEMORAL AUGMENT[CUSTOMER].
Description of Event or Problem · 0
DR. M INDICATES THAT THE PATIENT NEEDS FEMORAL-SIDE REVISION DUE TO PAIN AND AUDIBLE CLICKING THAT DR. M BELIEVES IS RELATED TO MOVEMENT AT THE UHMWPE FEMORAL AUGMENT. [CUSTOMER].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1677958 | ENDO MODEL MODULAR KNEE PROTHESIS SYSTEM | FEMORAL SPACER, S4,80 MM, LARGE, LEFT,ENDO-M. MODUL. KNEEP. SYSTEM | KRO | WALDEMAR LINK GMBH & CO.KG | 15-2964/06 | 2122177 | |
| 1791563 | ENDO MODEL MODULAR KNEE PROTHESIS SYSTEM | FEMORAL SPACER, S4,80 MM, LARGE, LEFT,ENDO-M. MODUL. KNEEP. SYSTEM | KRO | WALDEMAR LINK GMBH & CO.KG | 15-2964/06 | 2122177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Required Intervention |