MAUDE Adverse Event Report: CARTIVA, INC CARTIVA IMPLANT; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Device Problem Degraded (1153)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

Literature citation: fogleman et al.Failed hydrogel synthetic cartilage implant with osteolytic cyst formation in the first metatarsophalangeal joint.Sagef journal.2020; volume 5 issue 3.The device was not returned for evaluation.Films in the article were provided and found to show post implantation of a synthetic cartilage implant.Imaging demonstrates ballooning osteolysis about the first mtp joint space.Mtp, metatarsophalangeal.

Event Description

Allegedly it was reported in a journal article titled failed hydrogel synthetic cartilage implant with osteolytic cyst formation in the first metatarsophalangeal joint p.The patient reported that since the time of the index procedure, the patient had continued to have pain and swelling about the great toe.Imaging at the time of this initial encounter demonstrated a right first mtpj status post implantation of the hydrogel implant with subsequent joint collapse, implant loosening, and ballooning osteolysis in both the first metatarsal and proximal phalanx.There was no evidence for cystic changes on radiographs prior to placement of her hydrogel implant.Because of the patients clinical appearance and radiographic findings, the patient was sent for blood work including erythrocyte sedimentation rate (esr), c-reactive protein (crp), and complete blood count (cbc) with differentiation, all of which came back with normal values.Additionally, a computed tomography (ct) scan of the right foot was ordered to further define bone loss.One month later, the patient returned for reevaluation.The patient was continuing to have pain and swelling about the great toe.After a discussion of the risks and benefits of surgery, we proceeded with right first mtpj removal of implant and fusion with cancellous autograft 3 weeks later.A dorsal approach was made over the first mtpj following the previous operative incision.There was a large degree of reactive tissue around the hydrogel implant.The implant was grossly loose, and it was removed without difficulty.The implant demonstrated pitting and wear.A curette was then used to excavate the cyst present within the metatarsal and phalanx.Cystic tissue was sent for culture and pathology.The patient received utologous cancellous bone graft and conversion to fusion.

Manufacturer Narrative

Literature citation: fogleman et al.Failed hydrogel synthetic cartilage implant with osteolytic cyst formation in the first metatarsophalangeal joint.Sagef journal.2020; volume 5 issue 3.H6: the case report provided images.Among the images was one of the cartiva device which the report claimed exhibited pitting and wear.Although the image does appear to confirm what looks like pitting and denting along the articular surface, it is not possible to confirm that these are attributed to wear without physically measuring and weighing the device.

Event Description

Allegedly it was reported in a journal article titled failed hydrogel synthetic cartilage implant with osteolytic cyst formation in the first metatarsophalangeal joint p.The patient reported that since the time of the index procedure, the patient had continued to have pain and swelling about the great toe.Imaging at the time of this initial encounter demonstrated a right first mtpj status post implantation of the hydrogel implant with subsequent joint collapse, implant loosening, and ballooning osteolysis in both the first metatarsal and proximal phalanx.There was no evidence for cystic changes on radiographs prior to placement of her hydrogel implant.Because of the patients clinical appearance and radiographic findings, the patient was sent for blood work including erythrocyte sedimentation rate (esr), c-reactive protein (crp), and complete blood count (cbc) with differentiation, all of which came back with normal values.Additionally, a computed tomography (ct) scan of the right foot was ordered to further define bone loss.One month later, the patient returned for reevaluation.The patient was continuing to have pain and swelling about the great toe.After a discussion of the risks and benefits of surgery, we proceeded with right first mtpj removal of implant and fusion with cancellous autograft 3 weeks later.A dorsal approach was made over the first mtpj following the previous operative incision.There was a large degree of reactive tissue around the hydrogel implant.The implant was grossly loose, and it was removed without difficulty.The implant demonstrated pitting and wear.A curette was then used to excavate the cyst present within the metatarsal and phalanx.Cystic tissue was sent for culture and pathology.The patient received utologous cancellous bone graft and conversion to fusion.

• Brand Name: CARTIVA IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• MDR Report Key: 11029434
• MDR Text Key: 222101638
• Report Number: 3009351194-2020-00020
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• PMA/PMN Number: K181348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/22/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 11/22/2020
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR