MAUDE Adverse Event Report: SYNTHES SELZACH GLENOID SCR EPOCA Ø3.5 L24 TAV; PROSTEHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 5526-24

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the patient had three revisions with a mix of depuy and synthes products.Initially the patient had a depuy reverse shoulder implanted (delta cta) in 2007.The first revision was on (b)(6) 2013, the patient fractured the glenoid and as there were no depuy products that would have supported the fracture, a synthes epoca cage was put into the glenoid.A delta stem and depuy hemi head remained in situ together.The second revision was on (b)(6) 2014, the patient had undergone further revision as a result of the synthes screws impinging and causing pain; the surgeon thought the screws were too long.In order to gain access to the screws, the depuy head was also removed and replaced.The surgeon did not make comments to indicate whether the patient dislocated due to soft tissue insufficiency or product performance.It is undetermined what caused the pain, so everything was taken out and was replaced with different hardware.This is report 3 of 6 for (b)(4).

Manufacturer Narrative

This device was used for treatment, not diagnosis.Date of event unknown.Device is not distributed in the united states, but is similar to device marketed in the usa.Investigation could not be completed, no conclusion could be drawn as no device was returned.The review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.There were no ncrs generated during production.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLENOID SCR EPOCA Ø3.5 L24 TAV
• Type of Device: PROSTEHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• MDR Report Key: 3988592
• MDR Text Key: 19718537
• Report Number: 3000270450-2014-10079
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5526-24
• Device Lot Number: 11A18940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention