MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-29 for ARTHROSURFACE TOEMOTION manufactured by Arthrosurface, Inc..
[37183952]
Patient was initially implanted with toemotion components on (b)(6) 0215. Since he developed pain and infection, the components were replaced with new ones except the taper post on the meta-tarsal side on (b)(6) 2016. The surgeon suspected that the implant might have loosened. A culture was obtained during the revision surgery. Later, the swab sample analysis revealed staphylococcus lugdunensis (coagulation negative staph). Should any further reportable information is received, supplemental report shall be filed. Following are the details of components explanted from the patient: 1. Part # 9m52-2545-w, lot # 75be1706, mfg dt: 05-2015, exp dt: 04-2022; 2. Part # 9p15-s180-a, lot # 75ae3004, mfg dt: 03-2015, exp dt: 03-2020; 3. Part # 9p15-pb01-a, lot # 75ae3014, mfg dt: 02-2015, exp dt: 02-2020.
Patient Sequence No: 1, Text Type: N, H10
[37183953]
The patient was re-operated since he developed pain, peri-prosthetic infection and osteomyelitis with arthrosurface toemotion implants. It was also reported that the initial implant was loosened as indicated by surgeon during the revision surgery.
Patient Sequence No: 1, Text Type: D, B5
[40331689]
Per the latest follow-up, all total toe components were removed from the patient due to staph infection and bone cement (spacer) with antibiotics was placed. It is not known as to what contributed to the infection. The surgeon plans on fusing the joint with allograft/ autograft bone or retaining the spacer if asymptomatic. The complaint is considered closed. No further follow-up required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004154314-2016-00001 |
| MDR Report Key | 5399918 |
| Date Received | 2016-01-29 |
| Date of Report | 2016-02-19 |
| Date of Event | 2016-01-29 |
| Date Mfgr Received | 2016-02-19 |
| Date Added to Maude | 2016-01-29 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PHANI PUPPALA |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal | 02038 |
| Manufacturer Phone | 5085203003 |
| Manufacturer G1 | PRIMO MEDICAL GROUP |
| Manufacturer Street | 75 MILL ST |
| Manufacturer City | STOUGHTON MA 02072 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHROSURFACE TOEMOTION |
| Generic Name | ARTHROSURFACE? TOTAL TOE - PROXIMAL PHALANX IMPLANT |
| Product Code | LZJ |
| Date Received | 2016-01-29 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROSURFACE, INC. |
| Manufacturer Address | 28 FORGE PARKWAY FRANKLIN MA 02038 US 02038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-29 |