FDA Adverse Event
Injury
Summary report: N
GMK SPHERE TIBIAL INSERT SIZE 5 / 10 MM LEFT
MDR report key: 6395100
·
Received March 10, 2017
Report
- Report Number
- 3005180920-2017-00108
- Event Type
- Injury
- Date Received
- March 10, 2017
- Date of Event
- February 9, 2017
- Report Date
- March 10, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 10 MARCH 2017: LOT 153759: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 NOVEMBER 2015. EXPIRATION DATE: 2020-10-27. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED PROBLEM.
Description of Event or Problem · 1
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177412 | GMK SPHERE TIBIAL INSERT SIZE 5 / 10 MM LEFT | UHMWPE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 153759 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |