MAUDE Adverse Event Report: ARTHROSURFACE, INC. ARTHROSURFACE TOEMOTION; ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 01/29/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: ARTHROSURFACE TOEMOTION
• Type of Device: ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill st; stoughton MA 02072
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, MA 02038 ; 5085203003
• MDR Report Key: 5399918
• MDR Text Key: 37183952
• Report Number: 3004154314-2016-00001
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 01/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR