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

Model Number CAR-10-US

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

The implant was returned for evaluation which found: scuffing and wear on the articulating surface of the device is not inconsistent with the scuffing observed in the cartiva on cartilage wear study which simulated the equivalent of 5 years of use.However, the degree of wear which compromises the shoulder of the device is atypical.The smooth nature of the wear, wherein borders are not well defined, is not consistent with damage incurred by removal technique such as use of rongeurs where material may be cut in chunks or have a "nipped" appearance.A single pin hole was observed extending from the top of the device to the lateral wall.This is likely present due to piercing of the implant with a guide pin in order to remove it from the bone cavity.The dimensions of the cartiva device were assessed using the optical comparator.Because the device exhibited a wide range of wear on the articulating surface, the height and width of the device was measured at low, mid, and max points around the circumference.The maximum height was measured in an area where the radiused shoulder of the device was intact.This height of 9.4mm is within the post-sterilization value range established through validation of the manufacturing process (9.0mm - 10.3mm).The two device height measurements taken in areas of substantial wear are significantly lower than specification, representing a 1.6mm undersize condition.The resolved device diameter was 10.0mm, which is slightly under the validated post-sterilization values (10.2mm - 11.0mm).This slight reduction in diameter is likely attributable to the long-term press fit within the cavity.This can be secondarily assessed as the theoretical diameter of the device at the point of maximum height, where the shoulder of the device is present, is 10.3mm as defined by continuing the line of the lateral wall of the device.The device was weighed three times using a calibrated scale with weight recorded as 0.7 g.Mass data recorded from fresh, sterile devices represent a range of 0.85- 0.93g, indicating measurable mass loss in the device, attributable to the areas of wear characterized above.Due to the location, quality, and size of the area of missing material, no definitive conclusion could be drawn as to a root cause.The degree of wear and mass loss is not representative of that seen in the 5-year simulated wear of cartiva against cartilage and is also not consistent with damage of the device by removal technique, such as use of rongeurs.As such, it would be important to understand if the surface of the phalanx abutting the device was considered to have any aggressive anatomical features, or if there were any additional procedures performed that might have altered the topography or surface of the phalanx.On november 10th, 2020 stryker trauma and extremities acquired cartiva, wright medical, tornier inc.And tornier (b)(4).An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr/vigilance process.

Event Description

It was reported that the patient underwent a surgical procedure.Allegedly, two years post-op the patient reported pain and underwent a revision and converstion to a hmpf with calcanea autograft the surgeon noticed a wear pattern.

• 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
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, TN 38117
• MDR Report Key: 13606052
• MDR Text Key: 290277996
• Report Number: 3009351194-2022-00054
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2019

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: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: CAR-10-US
• Device Catalogue Number: CAR-10-US
• Device Lot Number: F060116002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female