FDA Adverse Event
Injury
Summary report: N
GMK-PRIMARY TIBIAL INSERT FIXED SIZE 3 / 17 MM STD
MDR report key: 6249491
·
Received January 13, 2017
Report
- Report Number
- 3005180920-2016-00737
- Event Type
- Injury
- Date Received
- January 13, 2017
- Date of Event
- December 16, 2016
- Report Date
- February 16, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 09 JANUARY 2017. LOT 080425: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 APRIL 2008. EXPIRATION DATE: 2013-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (b)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION RECEIVED ON 17 JANUARY 2017 AND INCLUDES: THE TIBIAL INSERT WAS REMOVED AND REPLACED WITH A THICKER INSERT TO ADDRESS SOME INSTABILITY THAT OCCURRED OVER TIME WITH THE RELAXATION (STRETCHING) OF THE LIGAMENTS. THE OPERATION WAS PERFORMED WITHOUT ANY COMPLICATIONS.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON PLANNED TO SWAP THE POLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31562 | GMK-PRIMARY TIBIAL INSERT FIXED SIZE 3 / 17 MM STD | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 080425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |