MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. TURON SHOULDER; TURON PEGGED GLENOID, SZ 46MM, EPLUS

Catalog Number	521-01-246
Health Effect - Clinical Codes	Fall (1848); Discomfort (2330); Joint Dislocation (2374)
Date of Event	12/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient having complained of discomfort and of dislocation after a fall.After the revision was complete the surgeon concluded the implants were all in proper position and in good condition, but the patient had no rotator cuff remaining and needed a reverse shoulder implant.
Additional Manufacturer Narrative
The reason for this revision surgery was discomfort and dislocation.After the revision was complete, the surgeon concluded the implants were all in proper position and in good condition but the patient had no rotator cuff remaining and needed a reverse shoulder implant.The in-vivo length of patient service for the implant was 7.4 months.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The hospital retained ownership of the device for 2-3 weeks; it has not been made available to djo surgical for examination.A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions and specifications in effect at the time the part was manufactured were met.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed as non-product related.The complaint states the patient suffered a fall after the original surgery which led to a dislocation and discomfort.The surgeon examined the patient and found all the components were in the proper position but the rotator cuff had been damaged; and reported the dislocation was due to soft tissue.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: TURON SHOULDER
• Common Device Name: TURON PEGGED GLENOID, SZ 46MM, EPLUS
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 6230487
• Report Number: 1644408-2016-01050
• Device Sequence Number: 716932
• Product Code: KWS
• UDI-Device Identifier: 00888912024921
• UDI-Public: (01)00888912024921
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K123982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 521-01-246
• Device Lot Number: 800N1022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 520-00-000,LOT 878C1507; 520-46-120,LOT 925C1026; 521-01-246,LOT 800N1022
• Outcome Attributed to Adverse Event: Required Intervention