MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-13 for LPS FEM TO SLEEVE ADAPTER +0 1987-06-000 198706000 manufactured by Depuy Orthopaedics Inc Us.
[186297394]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[186297395]
It was reported that the patient originally had sigma revision components that were revised on (b)(6) 2019 because the femoral component was internally rotated which led to poor patella tracking and subluxation. On (b)(6) 2019, an lps hinged knee and metaphyseal sleeve were implanted to address the patella tracking issue. Since this procedure, the femoral construct had subsided approximately 3cm. These components needed to be revised to restore the joint line. The femoral construct was removed and a competitor cone was implanted along with a 200mm cemented lps stem, xsmall lps segmental femur and 25mm segment. Doi: (b)(6) 2019, dor: (b)(6) 2020, right knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07797 |
| MDR Report Key | 9829984 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2019-06-05 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LPS FEM TO SLEEVE ADAPTER +0 |
| Generic Name | LPS AND S-ROM : KNEE FEMORAL ACCESSORY |
| Product Code | KRO |
| Date Received | 2020-03-13 |
| Model Number | 1987-06-000 |
| Catalog Number | 198706000 |
| Lot Number | J3998F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |