MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PRO-DENSE¿; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	87SR0050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Discoloration (2074); Burning Sensation (2146); Ambulation or Postural Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Reaction to Medicinal Component of Device (4574); Swelling/ Edema (4577)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device remains implanted in patient.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to treat intraosseous lesion/neoplasm of the third metatarsal proximal metaphysis of the left foot.A few weeks post-op the patient noticed swelling, burning throbbing, gets really red or purple/black at times.Patient experiences spasm.Patient mentioned that she had noticed some swelling and discoloration post surgery but area was bandaged and didn't see how bad it was until the 2 week follow up.Patient cannot put too much weight on the foot, she is in a walking shoe.Patient has an allergy to latex and bromine.Patient is still being treated by primary doctor and meeting with a pain management doctor.
Additional Manufacturer Narrative
Correction b2 the reported event could be confirmed, since imaging provided, and office visit notes confirm the reported issue.The medical affairs team was consulted and asked to review available information.Per their review, "it is known that spill of such a filler can cause temporary soft tissue inflammation, yet, in this case such a spill is not apparent on the postoperative x-rays.The clinical picture that is described by the treating physician corresponds with autonomic disfunction.Autonomic disfunction is well-known after trauma and after surgery of the hand and the foot.The purple discoloration is posture-, and temperature-dependent (usually very visible after showering) and is caused by the decrease of the speed of blood flow and dysregulation of the vasoconstriction and vasodilation, giving the blood more time to deliver oxygen to the tissues and making the blood darker, shining purple through the skin.In conclusion, autonomic dysfunction (a condition in which the autonomic nervous system (ans) does not work properly.This may affect the functioning of the blood vessels) after surgery of the foot, causing discomfort and discoloration of the skin.These signs and symptoms are temporarily most of the times." based on investigation, the root cause was attributed to an anticipated procedural related issue.The issue is a known possibility after trauma and after surgery of the hand and the foot.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to treat intraosseous lesion/neoplasm of the third metatarsal proximal metaphysis of the left foot.A few weeks post-op the patient noticed swelling, burning throbbing, gets really red or purple/black at times.Patient experiences spasm.Patient mentioned that she had noticed some swelling and discoloration post surgery but area was bandaged and didn't see how bad it was until the 2 week follow up.Patient cannot put too much weight on the foot, she is in a walking shoe.Patient has an allergy to latex and bromine.Patient is still being treated by primary doctor and meeting with a pain management doctor.Update: the patient underwent a revision surgery to remove the prodense from her foot.

• Brand Name: PRO-DENSE¿
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14628635
• Report Number: 3010667733-2022-00196
• Device Sequence Number: 14989295
• Product Code: MQV
• UDI-Device Identifier: 00889797072755
• UDI-Public: 00889797072755
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/03/2025
• Device Model Number: 87SR0050
• Device Catalogue Number: 87SR0050
• Device Lot Number: 1696420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 47 KG