MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3 01.12.023 manufactured by Medacta International Sa.
[188223750]
Batch review performed by medacta regulatory affairs department on 13 march 2020: lot 163265: (b)(4) items manufactured and released on 02-sep-2016. Expiration date: 2021-08-18. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar event reported. Clinical evaluation performed by medical affairs manager: partial hip revision surgery (stem and head) performed 3 years after cementless total hip arthroplasty in a (b)(6) year old farmer. Radiological images provided show the presence of radiolucent lines in gruen zones 1, 2, 6 and 7 and signs of stress shielding suggesting stem mobilization. Aseptic loosening is a possible literature described adverse event after cementless total hip arthroplasty and causes are often unknown. Early return to high level of activities may reduce primary stability of the stem and hinder implant fixation. No conclusion can be drawn on the basis of available information.
Patient Sequence No: 1, Text Type: N, H10
[188223751]
Revision surgery performed 3 years and 1 month after the primary surgery due to the proximal loosening of a quadra h stem. The surgeon revised the stem and ball head. The patient was a heavy working farmer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2020-00203 |
| MDR Report Key | 9896985 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2016-09-02 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR STEFANO BAJ |
| Manufacturer Street | STRADA REGINA |
| Manufacturer City | CASTEL SAN PIETRO, SWITZERLAND 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6874 |
| Manufacturer G1 | MEDACTA INTERNATIONAL SA |
| Manufacturer Street | STRADA REGINA |
| Manufacturer City | CASTEL SAN PIETRO, 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3 |
| Generic Name | CEMENTLESS HIP STEM |
| Product Code | JDI |
| Date Received | 2020-03-30 |
| Model Number | 01.12.023 |
| Catalog Number | 01.12.023 |
| Lot Number | 163265 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDACTA INTERNATIONAL SA |
| Manufacturer Address | STRADA REGINA CASTEL SAN PIETRO, 6874 SZ 6874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |