MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN GII ANCHOR; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number UNK GII ANCHOR

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Tissue Damage (2104); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical product: unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: justin mitchell et al, 2017, " glenoid erosion leading to contact with retained metallic suture anchors: bilateral metallosis after bilateral shoulder hemiarthroplasty", the journal of bone and joint surgery volume 7 number 2 pages 1-6, usa.The study emphasized the glenoid erosion leading to contact with retained metallic suture anchors.Performed a bilateral metallosis after bilateral shoulder arthroplasty due to osteoarthritis.The patients evaluated on course of this study: a (b)(6)-year-old man presented to our clinic with substantial dysfunction and limited range of motion of both shoulders.He had undergone previous open and arthroscopic anterior stabilization procedures for glenohumeral instability at outside institutions approximately 6 years prior to presentation.These symptoms were associated with pain that limited activities of daily living and recreational activity and caused difficulty with job-related activities.The most recent arthroscopic stabilization procedures had been performed utilizing titanium metal glenoid suture anchors (gii anchor; mitek sports medicine), which were placed from approximately the 2:00 to 5:00 position on the anterior aspect of the glenoid for labral repair, and anterior capsulorrhaphy.The patient reported no noteworthy symptomatology or dislocation events for the intervening 6-year time frame following the stabilization procedures but presented to us with symptoms of bilateral shoulder pain.The article describes the following procedure: the patient underwent bilateral shoulder hemiarthroplasty with cobalt-chromium alloy (co-cr-mo) humeral resurfacing, first on the right shoulder and 2 months later the left shoulder, without complication.At the time of both arthroplasty procedures, the metallic anchors were not grossly visible on the face of the glenoid or at the anterior edge, and it was felt that attempts at removal would likely cause more damage to the glenoid than could be tolerated during a hemiarthroplasty procedure without glenoid resurfacing.The patient progressed well and was symptom-free for several years.However, approximately 3.5 years after the right shoulder hemiarthroplasty, he presented with increasing pain and a subjective grinding sensation in the right shoulder radiographs obtained at that time revealed medial glenoid erosion, but without compromise of the metal anchors.The patient was given the option of close follow-up and serial radiographs or conversion to tsa.Given the extensive surgical history, he had a strong desire to avoid revision if possible, and it was agreed that he would undergo serial radiographic evaluation of both shoulders.Bilateral revision surgery with removal of the anchors and conversion to tsa was recommended after 12 months.Complaining with persistent and progressive bilateral shoulder pain.Radiographs revealed substantial glenoid erosion in the right shoulder, with loosening of the hemi prosthesis and surrounding osteolysis.The metallic suture anchors, which previously had been placed in the glenoid, had been nearly completely eroded by the humeral prosthesis, and there had been substantial progression of glenoid wear.The left shoulder demonstrated similar findings.The patient again was counseled to consider bilateral tsa.The devices involved were: titanium metal glenoid suture anchors (gii anchor; mitek sports medicine) complications mentioned in the case report were: - radiographs revealed substantial glenoid erosion in the right shoulder, with loosening of the hemi prosthesis and surrounding osteolysis.The metallic suture anchors, which previously had been placed in the glenoid, had been nearly completely eroded by the humeral prosthesis, and there had been substantial progression of glenoid wear.Substantial metallic soft-tissue staining was noted around the prosthesis on either side, and superficial abrasions were noted on the humeral prosthesis, consistent with contact wear.Loose intra-articular metallic debris was noted, and the humeral prosthesis was slightly loose and was able to be removed by hand.There was also visible erosion of the glenoid with compromise and wearing of each remaining metallic suture anchor.Culture specimens of the soft tissue and debris were collected and maintained for microbial and pathologic evaluation.Results revealed no evidence of infection, and the gross specimen was consistent with metallosis without evidence of acute inflammation.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Age or date of birth & sex: upon complaint review, it was determined that the patient age at the time of event and sex were inadvertently missed on the initial report; therefore, both fields have been updated accordingly to reflect the correct information.

• Brand Name: UNKNOWN GII ANCHOR
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9266152
• MDR Text Key: 184870994
• Report Number: 1221934-2019-59369
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK GII ANCHOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR