MAUDE Adverse Event Report: ARTHROSURFACE HEMICAP PATELLO- FEMORAL WAVE RESURFACING PROSTHESIS; KNEE JOINT PATELLO-FEMORAL RESURFACING PROSTHESIS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Implant Pain (4561)

Event Type  malfunction  

Event Description

On (b)(6) 2022 during routine surveillance of the fda maude database, mw5106026.Was identified.The patient reported a full revision of the left knee which was recorded and investigated on a previous complaint and reported on mdr # 3004154314-2021-00004 for the investigation of the revision procedure for the patient's left knee.However, the patient also reported another procedure being required (not yet scheduled per the narrative) for a revision procedure on the patient's right knee stating that the implant is no longer in the proper position in the right knee".There is no report of any malfunction or adverse event reported by the patient directly or clinic.It is unknown at this time if the right knee implant was revised.This case is still under investigation to confirm if the revision procedure was performed as well as denitrifying the part / lot numbers of the initial implant devices.

Manufacturer Narrative

This case is still under investigation at the manufacturing plant.Additional information is currently being solicited.A supplemental report will be submitted upon receive of new and relevant information or upon completion of the investigation by the manufacturing plant.

Event Description

On 01apr2022 during routine surveillance of the fda maude database, mw5106026 was identified.The patient reported a full revision of the left knee which was recorded and investigated on a previous complaint and reported on mdr # 3004154314-2021-00004 for the investigation of the revision procedure for the patient's left knee.However, the patient also reported another procedure being required (not yet scheduled per the narrative) for a revision procedure on the patient's right knee stating that the implant is no longer in the proper position in the right knee".There is no report of any malfunction or adverse event reported by the patient directly or clinic.It is unknown at this time if the right knee implant was revised.This case is still under investigation to confirm if the revision procedure was performed as well as identifying the part / lot numbers of the initial implant devices.Additional information: additional information was solicited to the hospital and it was reported back to (b)(6) on 18nov2022 that there was no record of a revision procedure performed on the patient's right knee.

Manufacturer Narrative

This case is still under investigation at the manufacturing plant.Additional information is currently being solicited.A supplemental report will be submitted upon receive of new and relevant information or upon completion of the investigation by the manufacturing plant.Additional information: there was no revision procedure for this device.As a result, this case will be closed as a noncomplaint and redocumented as feedback.This case will be re-assessed upon receipt of new and relevant information.If additional information is received, a supplemental report will be submitted upon receipt of new and relevant information.

• Brand Name: HEMICAP PATELLO- FEMORAL WAVE RESURFACING PROSTHESIS
• Type of Device: KNEE JOINT PATELLO-FEMORAL RESURFACING PROSTHESIS
• Manufacturer (Section D): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): PRIMO; 75 mill street; stoughton MA 02072
• Manufacturer Contact: keith kelly ; 28 forge parkway; franklin, MA 02038
• MDR Report Key: 15668686
• MDR Text Key: 307156681
• Report Number: 3004153414-2022-00008
• Device Sequence Number: 1
• Product Code: KRR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female