FDA Adverse Event
Injury
Summary report: N
GMK SPHERE TIBIAL INSERT
MDR report key: 7731844
·
Received July 30, 2018
Report
- Report Number
- 3005180920-2018-00581
- Event Type
- Injury
- Date Received
- July 30, 2018
- Date of Event
- July 9, 2018
- Report Date
- July 30, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826412
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 26 JULY 2018: LOT 172780: 30 ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2017. EXPIRATION DATE: 2022-07-06. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
ABOUT 7 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A MINOR KNEE INSTABILITY. ONLY LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573638 | GMK SPHERE TIBIAL INSERT | PE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 172780 | 07630030826412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |