MAUDE Adverse Event Report: SYNTHES USA GLENOID 48MM-STERILE; PROSTHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 5213-48

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Impaired Healing (2378); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: an epoca glenoid and metalback was revised after approximately eight years within the patient.Revision was being done due to rotator cuff failure and the need to implant a reverse prosthesis.Upon exposure it was discovered that the entire superior half of the polyethylene glenoid had worn completely through.In addition, the superior half of the metalback had worn through, leaving only the peg remaining in the superior portion.Due to this metal wear, black residue (understood to be titanium remnants) had filled the joint space.Surgeon was unaware of the extent of implant wear until the revision operation; there was a prolongation of surgery by thirty minutes.The event occurred over time in situ following historic implantation.The patient outcome was reported as excellent following revision to reverse prosthesis; however the surgeon is unsure of the consequences the metallosis would bring to patient.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Event date: unknown.Additional product codes: mbf and hsd.Implant date: (b)(6) 2008.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Manufacturer Narrative

A product development evaluation was completed: no device was received.The design and clinical risk management has been investigated.Based on the provided information and without material no further evaluation is possible, but considering the available data, the listed implants can be considered as safe and efficient.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.

• Brand Name: GLENOID 48MM-STERILE
• Type of Device: PROSTHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4202817
• MDR Text Key: 4981593
• Report Number: 2520274-2014-14360
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5213-48
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 60