MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	AR-9503S-06
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The contribution of the device to the event as reported could not be determined as the device was not returned for evaluation.As stated in the event, the patient dislocated the repair to the humeral insert.Lot number was not provided so device history record review cannot be performed.The most likely cause(s) of this event include non-compliance to the post-op protocol or post-op trauma to the surgical site.Per device directions for use, until bone healing is complete, fixation given with this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device reported to be discarded by user.
Event or Problem Description
It was reported that a patient had previously dislocated their shoulder and had a repair performed using an ar-9503s-06, arthrex univers reverse humeral insert.The patient dislocated the previous repair on (b)(6) 2016.Patient was seen by the surgeon shortly after that.An open poly exchange took place on (b)(6) 2016 for the patient's right shoulder.The humeral insert s/36/+6 (lot: 2501250702) was removed and exchanged for a titanium spacer (lot: 2501464807) and small 36 +3 arthrex univers revers humeral insert (lot: 160043709).

• Brand Name: HUMERAL INSERT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6085150
• Report Number: 1220246-2016-00493
• Device Sequence Number: 13642563
• Product Code: KWS
• UDI-Device Identifier: 00888867061316
• UDI-Public: 00888867061316
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K143749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2016

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 Catalogue Number: AR-9503S-06
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other