MAUDE Adverse Event Report: SYNTHES SELZACH PE-INLAY EPOCA RECO SIZ 42 R; PROSTEHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 5333-42R

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)(4) as follows: it was reported that the patient initially had a depuy reverse shoulder implanted (delta cta) in 2007.On (b)(6) 2013, the patient fractured the glenoid and as there were no depuy products that would have supported that fracture.A synthes epoca cage was put into the glenoid, a delta stem and the depuy hemi head remained in situ together.On (b)(6) 2014 the patient had undergone a 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.It is undetermined what caused the pain, so everything was taken out and was replaced with different hardware.On (b)(6) 2014 the patient had then undergone a third revision due to head dislocation by the same surgeon and at the same hospital.There was no trauma involved that could have contributed to the reported dislocation.An x- ray photo is provided on an unknown date.The surgeon did not make comments to indicate whether the patient dislocated due to soft tissue insufficiency or product performance.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

This device was used for treatment, not diagnosis.Date of event unknown.An image reading of the x-rays was conducted by a medical director from this manufacturer.The medical director says , i can confirm head dislocation can be observed.Additional codes: mbf, hsd.(b)(6).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.Pma/510k number: device is not distributed in the united states, but is similar to device marketed in the usa.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PE-INLAY EPOCA RECO SIZ 42 R
• 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
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3988776
• MDR Text Key: 4750433
• Report Number: 3000270450-2014-10076
• 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: 5333-42R
• Device Lot Number: 13A18239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2014
• Date Device Manufactured: 06/12/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention