MAUDE Adverse Event Report: SYNTHES SELZACH GLENOID 54MM-STERILE; PROSTHESIS,SHOULDER,NONCONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 5213-54

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient initials, gender and weight not provided by reporter.Additional product codes: mbf, hsd.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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.

Event Description

Device report from synthes eu reports an event in the (b)(6) as follows: it was reported that there was an early failure of an implant with delamination of poly for a primary total shoulder replacement (tsr).Patient underwent revision to reverse tsr with bone graft to glenoid.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a manufacturing investigation, product development evaluation and device history records review were performed for the subject device (part number 5213-54, glenoid 54mm-sterile, lot number 06a15998).The received epoca glenoid is completed worn out and fragmented.This makes it impossible to verify the dimensions of the device.The examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding, dimensions, material analysis, strength and structural stability.The values were in compliance with the standards for implants for surgery - ultra-high molecular weight polyethylene.The review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No ncrs were generated during production.The manufacturing documents indicate that the epoca glenoid was manufactured according to the specification.The lot in question was manufactured with a lot size of (b)(4) pieces in february 2007.Based on the provided information, no clinical details of the implantation, no x-rays or information about post-operative activities, we are not able to determine the exact root cause of this occurrence.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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 54MM-STERILE
• Type of Device: PROSTHESIS,SHOULDER,NONCONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5056524
• MDR Text Key: 25010165
• Report Number: 3000270450-2015-10174
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2011
• Device Catalogue Number: 5213-54
• Device Lot Number: 06A15998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention