MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for PIP UNKNOWN XXX-PIP manufactured by Ascension Orthopedics.
[145489979]
The device is not expected to be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. Linked to mfg report number: 3003418325-2019-00016.
Patient Sequence No: 1, Text Type: N, H10
[145489980]
This is 2 of 2 reports. The journal j hand surg am (2018) published: "medium-term outcomes with pyrocarbon proximal interphalangeal arthroplasty: a study of 170 consecutive arthroplasties. " the purpose of this study was to examine the medium-term outcomes of patients undergoing proximal interphalangeal (pip) joint arthroplasty using a pyrocarbon implant. Methods: the study comprised an analysis of 170 pip joint pyrocarbon arthroplasties in 99 patients with a minimum 2-year clinical follow-up. Diagnoses included inflammatory arthritis, posttraumatic arthritis, and osteoarthritis. Univariate logistic regression and kaplan-meier survival analyses were performed. Results: at an average follow-up of 6 years (range, 2-14 years), 58 reoperations (34%) were required, including 36 (21%) involving implant revision surgery. The majority of revisions were performed for either dislocations (n = 16) or pain and stiffness (n =14). The 5- and 10- year survival-free of revision surgery rates were 79% and 77%, respectively. The risk for revision surgery was higher in patients with posttraumatic arthritis. There were 15 intraoperative complications involving a fracture and 26 postoperative complications, including 21 dislocations. In unrevised implants, patients had significant improvements in their preoperative to postoperative pain levels, with no change in their pip joint total arc of motion. At a mean radiographic follow-up of 5. 4 years, there were 28% with grade 3+ loosening and 36% with progressive implant instability. Implant loosening or progressive instability was not associated with worse pain or pip joint total arc of motion. Conclusions: approximately 1 in 5 pip joint arthroplasties with a pyrocarbon implant will require revision surgery by 5 years, and 1 in 3 will undergo more than 1 operation. Furthermore, 1 in 4 pip joint arthroplasties will have grade 3+ radiographic loosening and 1 in 3 will have progressive loosening or subsidence by 5 years. These results are particularly concerning in young patients and those with posttraumatic arthritis. Overall, in patients that do not require revision surgery, pain relief was improved and motion maintained. Doi. Org/10. 1016/j. Jhsa. 2018. 06. 020. Malfunctions: dislocations (21) - revisions (16); recurrent subluxation with revision (3); implant loosening with revision (2).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00017 |
| MDR Report Key | 8619413 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-04-23 |
| Date Mfgr Received | 2019-06-28 |
| Date Added to Maude | 2019-05-17 |
| 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 | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PIP UNKNOWN |
| Generic Name | PIP |
| Product Code | NEG |
| Date Received | 2019-05-17 |
| Catalog Number | XXX-PIP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-17 |