MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-12-11 for UNKNOWN FINGER IMPLANT UNK FINGER manufactured by Depuy Orthopaedics Inc Us.
[185413247]
Product complaint # (b)(4). Investigation summary ==> no device was received. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. Investigation methods: was patient affected: yes. Device history reviewed: no. Lot trace obtained: no. Complaints database searched: no. Product checked: no. Label checked: no. Product pulled from stock for inspection: no. A review of complaint databases was not possible as no product details were received. It should be noted that no device was returned. Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution. The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon. From the event information received, it was not possible to determine the relationship of the device to the reported event. No information received with this individual complaint indicated that a broader investigation or corrective action was necessary. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis. Post market surveillance is per (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185485341]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. No device was received. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. 2nd ip is to capture the poly cup. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185485342]
The literature article entitled "results with the roseland hac trapeziometacarpal prosthesis after more than 10 years? , written by a. Semere et al; published in chirurgie de la main 34 (2015) 59-66; was reviewed. The purpose of the study was to evaluate long-term outcomes? Functional, clinical and radiographic results---with the roseland hydroxyapatite-coated prosthesis (depuy). The study was retrospective, non-controlled, single-center study involving multiple surgeons. There were 75 patients (101 thumbs) that underwent cmc joint replacements using the roseland hac prosthesis between 1996 and 2002 undergoing clinical and radiological review in 2013. 24 patients were excluded, five refused to consent to participation, 14 were lost to follow-up and five had died by the time of review. In the end, 51 patients (64 thumbs) were included in the study. Mean follow-up was 12. 5 years. Osteophytes were also observed. All patients were satisfied to very satisfied with the majority reporting no pain or only occasional pain. Radiographically, implant subsidence and periprosthetic osteolysis were frequently observed. No dislocation at the time of the review. Complications occurred in 16 of 64 cases, six which required explanation of the prosthesis and were excluded from the review of the long-term clinical results. In one case, a traumatic trapezium fracture needed revision one year postoperatively, because of pain and functional deficits. After one and nine years, two implants had loosened from their trapezial socket without subsidence or visible trapezium fracture, significantly altering the cup orientation. These cases were traumatic, probably linked to excessive distraction or moments at the thumb, leading to separation of the bone-implant interface. One case of trapezium metallosis at seven years postoperatively was confirmed by histopathology analysis. In one case, pain was persistent 12 years after surgery in a context of pancarpal osteoarthritis. This condition appeared after the thumb cmc arthroplasty, and the patient underwent multiple carpal procedures that were unsuccessful at changing the pain level. All these patients underwent trapeziectomy with interposition of a non-depuy synthetic implant. Five other trapezium fractures occurred between 10 and 16 years postoperatively, three of which were discovered by chance; all were immobilized until the pain decreased. In these cases, the trapezial implant sank beyond the bottom of the fractured trapezium in the stt, without changing its orientation. The cause was traumatic, probably linked to excessive acute or repeated axial compression. Two neuromas of the dorsal branch of the radial nerve were treated by excision. Three case of complex regional pain syndrome (crps) resolved with conservative treatment. Although the complication rate was high, these complications typically occurred early, were due to trauma or brought on by a technical error during the surgery; seldom was prosthesis removal needed. Trapezium fractures were always traumatic (fall from standing height), but poor preoperative radiological assessment of trapezium height, or an error when centering the trapezial implant during the surgery may have contributed to early trapezium fractures; similarly, late trapezium fractures could have been due to progressive implant subsidence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-119902 |
| MDR Report Key | 9452306 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-12-11 |
| Date of Report | 2019-11-18 |
| Date Mfgr Received | 2019-11-28 |
| Date Added to Maude | 2019-12-11 |
| 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 | JTE WARSAW MFG SITE |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| 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 | 2019-12-11 |
| 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 US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-11 |