MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-13 for UNKNOWN FINGER IMPLANT UNK FINGER manufactured by Depuy Orthopaedics, Inc. 1818910.
[162795394]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[162795395]
Silicone metacarpophalangeal arthroplasty for osteoarthritis: long-term results. Update 27 aug 2019. ? Silicone metacarpophalangeal arthroplasty for osteoarthritis: long-term results? Was reviewed for mdr reportability. The study followed 35 patients (40 implants) who underwent surgery for metacarpophalangeal osteoarthritis. The average follow-up was 8. 3 years with an average patient age of 58 years old. It is noted specific patient identifiers nor specific revision information was provided. The following adverse events were noted: there was only one reported revision. Reason for revision was not specified. There were 5 cases of post-operative implant fracture without evidence of instability, pain, decreased range of motion, or symptoms of synovitis. The final average pain score (scale, 0-10) was 0. 3 of 10.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-104405 |
| MDR Report Key | 9030566 |
| Date Received | 2019-09-13 |
| Date of Report | 2019-08-27 |
| Date Mfgr Received | 2019-10-09 |
| Date Added to Maude | 2019-09-13 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6103142063 |
| 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 FINGER IMPLANT |
| Generic Name | FINGER IMPLANT |
| Product Code | KYJ |
| Date Received | 2019-09-13 |
| Catalog Number | UNK FINGER |
| 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. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-09-13 |