MAUDE Adverse Event Report: SYNTHES SELZACH HEAD EPOCA Ø54 H20.25 SST; PROSTHESIS,SHOULDER,NONCONSTRINED, METAL/POLYMER CEMENTED

Catalog Number 5311-54/20

Device Problem Unintended Movement (3026)

Patient Problem Irritation (1941)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional codes mbf, hsd.(b)(6).Manufacturing location: (b)(4).Supplier: external supplier.Manufacturing date: 27.March 2015 expiry date: 01.March 2020.No nonconformances were generated during production.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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 europe reports an event in (b)(6) as follows: it was reported that a young patient had a fracture of the proximal humerus.He was treated by the epoca shoulder prothesis system.A few month later he felt uncomfortable and shown up to the surgeon to examinations.After the x-ray the surgeon saw that, the epoca head was displaced.So he decided the revision surgery.He took out all the implants and was treated with the same epoca prosthesis system.Patient is okay.Concomitant parts reported: 1x epoca system 5614-8/12 lot.15a14726.1x epoca excenter 5413-20/5 lot.15c14730.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

X-rays taken on (b)(6) 2016.510k: device is not distributed in the united states, but is similar to device marketed in the usa.A manufacturing investigation was performed.We have received the following part for investigation: part 5311-54/20 / #lot 15a16029 / head epoca ø 54mm, height 20.25mm; part 5614-8/12 / #lot 15a14726 / humeral stem epoca, cemented, 8, l 120mm (concomitant part); part 5413-20/5 / #lot 15c14730 / eccenter epoca (concomitant part).The parts were forwarded to the responsible supplier ((b)(4)) for further evaluation with the following results: the material certificates were checked and no deviations were found.Also, no defects could be detected during the incoming inspection.No nonconformity reports were generated during production.The review of the device history records (dhr) showed that all values are within tolerance and meet the requirements.No nonconformity could be found.The returned products cannot be subjected to a dimensional inspection.During disassembly, the parts were damaged.Because of these injuries, it is not useful to measure the dimensions.The outer diameter of the eccentric pin and the inner diameter of the stem and head were inspected 100% during manufacturing process.The measurement data from the production of the products are all in tolerance and were checked together with the dhr review.All components have injuries and scratch marks.These occurred during the assembly or disassembly (more likely) during the surgery.These errors would be noticed by internal inspections.This error did not occur at (b)(4).The assembly is performed during the surgery.Due to the injuries of the parts, no functional test can be carried out.All products were measured according to the internal test specification.All results fulfilled the specifications and are documented.All inspections during manufacture meet the specifications.Probably the parts were not assembled correctly during the surgery.This could be the reason, that the epoca head was displaced.No indication for product related issue was found.It is unknown when the epoca head was displaced.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: HEAD EPOCA Ø54 H20.25 SST
• Type of Device: PROSTHESIS,SHOULDER,NONCONSTRINED, 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6349798
• MDR Text Key: 68038829
• Report Number: 3000270450-2017-10052
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 5311-54/20
• Device Lot Number: 15A16029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE QTY PART # 5413-20/5 LOT #15C14730; ONE QTY PART # 5614-8/12 LOT #15A14726
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 105