MAUDE Adverse Event Report: SYNTHES SELZACH TI RECO SUPPORT, SIZE 42 STERILE; PROSTHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 5134-42

Device Problem Unintended Movement (3026)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation, as it was reportedly discarded by the facility.(b)(6) device is not distributed in the united states, but is similar to device marketed in the usa.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 (b)(4) reports an event in australia as follows: it was reported the patient had four shoulder procedures.The fourth revision procedure was performed on (b)(6) 2016 due to the patient experiencing pain and the glenoid implant loosening.All the implants were removed and delta xtend devices were implanted.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

(other): udi # (b)(4).Reported lot # 09a18238 was incorrect.Possible lot # is 09a18236.Device history records review was completed for part # 5134-42, lot # 09a18236.Manufacturing site: (b)(4), supplier: (b)(4), manufacturing date: jul 22, 2009, expiry date: jun 01, 2014.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Initial reporter name and address contact number (b)(6).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 RECO SUPPORT, SIZE 42 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6063308
• MDR Text Key: 58658843
• Report Number: 3000270450-2016-10257
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2014
• Device Catalogue Number: 5134-42
• Device Lot Number: 09A18236
• Other Device ID Number: (01)07611819950474(10)09A18238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention