MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE SHOULDER; ALTIVATE ANATOMIC, PEGGED GLENOID TRIAL, SIZE 54

Catalog Number	804-07-540
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint - the glenoid trial was creating a rocking effect after preparation.The surgeon prepared the glenoid again with the same result.He implanted a 54 mm glenoid and did not like the result.He then removed the implant and converted to a reverse.
Additional Manufacturer Narrative
Corrected data: added primary surgery to description of event.
Event or Problem Description
Complaint/primary surgery - the glenoid trial was creating a rocking effect after preparation.The surgeon prepared the glenoid again with the same result.He implanted a 54 mm glenoid and did not like the result.He then removed the implant and converted to a reverse.
Additional Manufacturer Narrative
The items listed were not returned therefore the complaint could not be confirmed.The product feedback form notes that the trials will be returned when new ones arrive.The returned materials authorization (rma) issued for the return of the items was used for the return of the replacements which would have the same result as the complaint.This event occurred during surgery near the patient.There was not another suitable device available.The incident did cause a 40 minute delay in surgery.A significant adverse event was reported; however, the surgery was completed as intended.The instrument was inspected prior to surgery and was found to be acceptable.A review of the device history record (dhr)'s, of lots produced to date, revealed no discrepancies or issues with the manufacturing history of the parts.All parts conformed to design and manufacturing specifications at the time of manufacture.No ncmr's were associated with the parts.The summary of complaints is as follows: 1- functional and 2- fit.The root cause is that the radius at the base of the peg of the glenoid trial can lead to a rocking action.
Additional Manufacturer Narrative
Corrected data: added concomitant part 521-07-254.Manufacturer narrative: the items listed were not returned therefore the complaint could not be confirmed.The product feedback form notes that the trials will be returned when new ones arrive.The returned materials authorization (rma) issued for the return of the items was used for the return of the replacements which would have the same result as the complaint.This event occurred during surgery near the patient.There was not another suitable device available.The incident did cause a 40 minute delay in surgery.A significant adverse event was reported; however, the surgery was completed as intended.The instrument was inspected prior to surgery and was found to be acceptable.A review of the device history record (dhr)'s, of lots produced to date, revealed no discrepancies or issues with the manufacturing history of the parts.All parts conformed to design and manufacturing specifications at the time of manufacture.No ncmr's were associated with the parts.Complaint database review showed previous complaints but there were no indications that these instruments have a design or material deficiency.The summary of complaints is as follows: 1- functional and 2- fit.The root cause is that the placement of the pegged glenoid trial can lead to a rocking action.

• Brand Name: ALTIVATE SHOULDER
• Common Device Name: ALTIVATE ANATOMIC, PEGGED GLENOID TRIAL, SIZE 54
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7107905
• Report Number: 1644408-2017-01165
• Device Sequence Number: 11058383
• Product Code: PAO
• UDI-Device Identifier: 00190446174639
• UDI-Public: (01)00190446174639
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 804-07-540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 12/12/2017; 01/29/2018; 01/29/2018; 01/31/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 12/12/2017; 01/30/2018; 01/30/2018; 01/31/2018
• 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
• Patient Age: 62 YR