MAUDE Adverse Event Report: ARTHROSURFACE OVOMOTION SHOULDER ARTHROPLASTY SYSTEM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	G203-2015-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Hearing Impairment (1881); Failure of Implant (1924); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Tinnitus (2103); Vertigo (2134); Blurred Vision (2137); Visual Impairment (2138); Viral Infection (2248); Urticaria (2278); Shaking/Tremors (2515); Fibrosis (3167); Unspecified Nervous System Problem (4426); Eye Infections (4466); Eye Pain (4467); Cramp(s) /Muscle Spasm(s) (4521); Metal Related Pathology (4530); Ear infection (4813); Joint Impingement (4834)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.
Event or Problem Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by arthrosurface or its employees that the report constitutes an admission that the device, arthrosurface, or its employees caused or contributed to a potential patient event documented on this report.On (b)(6) 2024 anika received an unsolicited inquiry regarding the ovo® inlay shoulder arthroplasty system.The patient reported that the implant ate through the patient's bone and migrated clear through the plastic and all the patient's soft tissue (labrum, rotator cuff, etc.) and is near the chest wall.There was no specific report of a product defect.The patient reported that the clinic who performed the initial implant is now defunct.The original implant date was on or about (b)(6) 2018.The revision is reportedly scheduled for (b)(6) 2024.Additional information was solicited.This is one report of three for the same event.
Event or Problem Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by arthrosurface or its employees that the report constitutes an admission that the device, arthrosurface, or its employees caused or contributed to a potential patient event documented on this report.On 26 september 2024 anika received an unsolicited inquiry regarding the ovo® inlay shoulder arthroplasty system.The patient reported that the implant ate through the patient's bone and migrated clear through the plastic and all the patient's soft tissue (labrum, rotator cuff, etc.) and is near the chest wall.There was no specific report of a product defect.The patient reported that the clinic who performed the initial implant is now defunct.The original implant date was on or about on (b)(6) 2018.The revision is reportedly scheduled for on (b)(6) 2024.Additional information was solicited.This is one report of three for the same event.Supplemental report: on 21 october 2024, anika received a medwatch from the fda on 21october2024.Patient submitted (mw5159821) on 17sept2024.The medwatch is related to this complaint.The patient alleges that the attributed metallosis from cobalt fragments of the implant resulting in multiple adverse events.See h6 health effect - clinical code (e).The patient reportedly underwent a dnc that removed 11 polyps, patient reported immunological changes including decreased immunity and inflammation over the past 12 months.Patient alleges contracting hand, foot and mouth parvovirus two cases of strep throat, covid, eye and ear infections, uti infections treated by the pcp and urgent care.Patient reportedly scheduled for a reverse shoulder replacement due to the reportedly failed ovomotion shoulder arthroplasty on (b)(6) 2024.The patient alleges prosthetic eroding through the labrum and cartilage and completely thought the plastic.That the prosthetic is migrating through the plastic into the patient's bone at an angle which is moving into the patient's body, two screws being inside the joint was reportedly confirmed by x-rays (not provided) and ct scan, causing cobalt fragments and metallosis, a third screw is scratching the prosthetic causing metallosis and related cytokine storms and inflammation.Patient alleges that due to the failure the bone around the hemicap has developed bone spurs that prevent movement in the joint and is trying to encapsulate the prosthetic that is causing the inflammation.Patient reports pain, worsening crps, tremors and dystonia.The patient reported the following medical intervention: hydrolyzation procedure, mirror therapy, acupuncture, yoga, meditation, and pain management.Patient alleges loss of work as a result.This is one of three mdr submissions for the same event.
Additional Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Additional information: additional information was not provided upon request.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.
Additional Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Additional information: a2, a3a, a6, b5, e1, e4, additional information was not provided upon request.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Supplemental report #2.The reported event could not be confirmed.Additional information was requested but not provided.The device history record was reviewed.The device was manufactured and released to applicable procedures and specifications.There was no nonconformances in the record.The components device history record was also reviewed.There was no nonconformances related to the reported event.The cause of the reported event could not be established.A three year retrospective review of all nonconformances was performed.There was no nonconformances related to the reported event.A supplemental report will be submitted upon receipt of new and relevant information.This case will be monitored and trended for future analyis.
Event or Problem Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by arthrosurface or its employees that the report constitutes an admission that the device, arthrosurface, or its employees caused or contributed to a potential patient event documented on this report.On 26 september 2024 anika received an unsolicited inquiry regarding the ovo® inlay shoulder arthroplasty system.The patient reported that the implant ate through the patient's bone and migrated clear through the plastic and all the patient's soft tissue (labrum, rotator cuff, etc.) and is near the chest wall.There was no specific report of a product defect.The patient reported that the clinic who performed the initial implant is now defunct.The original implant date was on or about (b)(6) 2018.The revision is reportedly scheduled for (b)(6) 2024.Additional information was solicited.This is one report of three for the same event.Supplemental report: on 21 october 2024 anika received a medwatch from the fda on 21october2024.Patient submitted (mw5159821) on 17sept2024.The medwatch is related to this complaint.The patient alleges that the attributed metallosis from cobalt fragments of the implant resulting in multiple adverse events.See h6 health effect - clinical code (e).The patient reportedly underwent a dnc that removed 11 polyps, patient reported immunological changes including decreased immunity and inflammation over the past 12 months.Patient alleges contracting hand, foot and mouth parvovirus two cases of strep throat, covid, eye and ear infections, uti infections treated by the pcp and urgent care.Patient reportedly scheduled for a reverse shoulder replacement due to the reportedly failed ovomotion shoulder arthroplasty on 04november2024.The patient alleges prosthetic eroding through the labrum and cartilage and completely thought the plastic.That the prosthetic is migrating through the plastic into the patient's bone at an angle which is moving into the patient's body, two screws being inside the joint was reportedly confirmed by x-rays (not provided) and ct scan, causing cobalt fragments and metallosis, a third screw is scratching the prosthetic causing metallosis and related cytokine storms and inflammation.Patient alleges that due to the failure the bone around the hemicap has developed bone spurs that prevent movement in the joint and is trying to encapsulate the prosthetic that is causing the inflammation.Patient reports pain, worsening crps, tremors and dystonia.The patient reported the following medical intervention: hydrolyzation procedure, mirror therapy, acupuncture, yoga, meditation, and pain management.Patient alleges loss of work as a result.This is one of three mdr submissions for the same event.

• Brand Name: OVOMOTION SHOULDER ARTHROPLASTY SYSTEM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill street; stoughton MA 02072
• Manufacturer Contact: keith kelly ; 28 forge parkway; franklin, MA 02038
• MDR Report Key: 20486099
• Report Number: 3004154314-2024-00031
• Device Sequence Number: 3600995
• Product Code: HSD
• UDI-Device Identifier: M528G2032015A0
• UDI-Public: M528G2032015A0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2024

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 Expiration Date: 02/12/2025
• Device Catalogue Number: G203-2015-A
• Device Lot Number: 75AH2015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 10/21/2024; 10/29/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 10/22/2024; 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2018
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Race: White