MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-02 for UNKNOWN KNEE PATELLA UNK KNEE PATELLA manufactured by Depuy Orthopaedics Inc Us.
[115781954]
(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
[115781955]
Patient was doing extremely well until approximately (b)(6) 2018, where he reported doing a "minor extension action when pushing a trolley. He had immediate onset of pain. He is unable to walk up and down stairs without pain and an able to sit for prolonged periods of time. He is aware of a clicking and catching sensation. X rays appear to show that the components are well fixed and that there may be a slightly oblique resection of the patella when the patella was resurfaced at time of primary surgery. A decision has been make to open the knee and remove the existing patella, recut the patella bone and then resurface the patella. On opening the knee, all components were well fixed. Scar tissue surrounded the patella button. The knee was slightly loose through the range of motion, the poly was removed and up sized to a thicker 12. 5mm insert. Patella was removed and repositioned. A new 41mm patella was inserted.
Patient Sequence No: 1, Text Type: D, B5
[120751330]
(b)(4). Investigation summary: no device associated with this report was received for examination. Depuy synthes considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. 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
| Report Number | 1818910-2018-65610 |
| MDR Report Key | 7742023 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-02 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-07-06 |
| Date Mfgr Received | 2018-09-13 |
| Date Added to Maude | 2018-08-02 |
| 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. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN KNEE PATELLA |
| Generic Name | KNEE PATELLA |
| Product Code | HTG |
| Date Received | 2018-08-02 |
| Catalog Number | UNK KNEE PATELLA |
| Lot Number | NI |
| 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 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-02 |