MAUDE Adverse Event Report: SYNTHES SELZACH TI ECCENTER-STERILE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 5413-20/5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sedation (2368)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported a patient with primary total shoulder prosthesis returned with pain.An arthroscopy was performed (b)(6) 2014 which showed signs of infection and a loose glenoid.Antibiotics were prescribed and a reoperation was planned to extract everything and change to an arthrex prosthesis, which they normally use.The epoca stem (un-cemented) was impossible to extract, the instrument broke and they had to change the plan.The decision was to put in a new epoca glenoid, eccenter and head.This resulted in a 1 hour delay, the patient slept in the operating room while the surgeon waited for the equipment.A new epoca glenoid,,all poly,was implanted together with a revision epoca eccenter and epoca head.The reason for the failure was the screw ( 03.401.077) in the extraction instrument (03.401.072 ) that broke.This report is for the epoca eccenter, part and lot number unknown.This is report 4 of 5 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of birth reported only as 1954.This report is for the epoca eccenter, part and lot number unknown.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.No nonconformance reports 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.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.

Manufacturer Narrative

A manufacturing investigation was conducted.The report indicates that: complained article forwarded to the legal manufacturer for evaluation.The investigation has shown that screw head is broken off from the screw.The articles where analyzed for conformance to print specifications as well as the device history record was researched.No abnormal findings were identified.Unfortunately we are not able to determine the exact cause which has led to this occurrence.We can only assume that a mechanical overload situation has led to the breakage.No product failure could be detected.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: TI ECCENTER-STERILE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA 19380 CH2; SZ 19380 CH25
• 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: 3871112
• MDR Text Key: 21448937
• Report Number: 2520274-2014-11761
• Device Sequence Number: 1
• Product Code: MBF
• 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,Followup,Followup
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5413-20/5
• Device Lot Number: 12H14730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 120