FDA Adverse Event
Injury
Summary report: N
NEXGEN PRECOAT CR-FLEX FEMORAL SIZE G-RT,
MDR report key: 6248372
·
Received January 12, 2017
Report
- Report Number
- 0001822565-2017-00174
- Event Type
- Injury
- Date Received
- January 12, 2017
- Date of Event
- September 5, 2016
- Report Date
- March 3, 2017
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- PMA / PMN Number
- PK023211
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: NEXGEN MOLDED CR-FLEX ARTICULAR SURFACE BLUE 10 MM, CATALOG NUMBER: 00597005010, LOT NUMBER: NI; ITEM NAME: NEXGEN PRECOAT STEMMED TIBIAL PLATE SIZE 7, CATALOG NUMBER: 00598005701, LOT NUMBER: NI.
Additional Manufacturer Narrative · 1
UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE BELONGED TO A DIFFERENT LOCATION. PLEASE SEE REPORT 3007963827-2017-00017.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED AN UNKNOWN GENITOURINARY/RENAL COMPLICATION APPROXIMATELY 9 MONTHS AFTER DATE IMPLANTED. IT ISUNCERTAIN IF THE EVENT IS DEVICE RELATED. THE OUTCOME IS STILL PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28689 | NEXGEN PRECOAT CR-FLEX FEMORAL SIZE G-RT, | PROTHESIS, KNEE | JWH | ZIMMER, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |