FDA Adverse Event
Injury
Summary report: N
STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 6
MDR report key: 10612279
·
Received October 1, 2020
Report
- Report Number
- 3005180920-2020-00657
- Event Type
- Injury
- Date Received
- October 1, 2020
- Date of Event
- September 1, 2020
- Report Date
- October 1, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030803260
- PMA / PMN Number
- K170845
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 10 (B)(6) 2020: LOT 1905536: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DIC-2019. EXPIRATION DATE: 2024-12-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE POST-OP X-RAYS TAKEN AFTER SURGERY INDICATED THAT THE STEM WAS UNDERSIZED. THE SURGEON DECIDED TO OPERATE ON THE PATIENT AGAIN (THE SAME DAY OF PRIMARY SURGERY) AND REVISED THE STEM SIZE 6 RIGHT WITH A SIZE 7 RIGHT AND THE CERAMIC HEAD. THE SURGERY WAS COMPLETE SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1078131 | STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 6 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 01.13.106R | 1905536 | 07630030803260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |