MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS STEM, SIZE 7, CAP COATED; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	AR-9501-07CPC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This is the first of two submissions for the same patient event.The other is 1220246-2016-000562 ((b)(4) (b)(6)).At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Device history record review revealed nothing relevant to this event.Additional information has been requested but not made available.This is the first complaint of this type for this part/lot combination.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 requested but not yet received.
Event or Problem Description
It was reported that cup ar-9502-39rcpc, lot 150006510, line 176623 could not be mounted on shaft ar-9501-07pc, lot 150023110, line (b)(6).Screw could be screwed in, however, cup did not fit into the nut on the top of the shaft.Surgeon opened two additional cups to use the screws to try to fix the cup to the shaft, however, without success.Surgeon tried several cups and was finally able to connect an ar-9502-39cpc cup on a ar-9501-08cpc shaft.Surgeon had to do a partial resection at the humerus with a rasp to make components fit.
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.This is a follow-up submission due to device evaluation.This is the first of two submissions for the same patient event.The other is 1220246-2016-000562f1 ((b)(4)) device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed that the cups locking screws did not advance into the stem's threads.In addition, the locking screws leading threads and stem's leading threads are damaged.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.This is the first complaint of this type for this part/lot combination.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.
Event or Problem Description
It was reported that cup ar-9502-39rcpc, lot 150006510, line 176623 could not be mounted on shaft ar-9501-07pc, lot 150023110, line 176338.Screw could be screwed in, however, cup did not fit into the nut on the top of the shaft.Surgeon opened two additional cups to use the screws to try to fix the cup to the shaft, however, without success.Surgeon tried several cups and was finally able to connect an ar-9502-39cpc cup on a ar-9501-08cpc shaft.Surgeon had to do a partial resection at the humerus with a rasp to make components fit.

• Brand Name: UNIVERS REVERS STEM, SIZE 7, CAP COATED
• 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: 6173251
• Report Number: 1220246-2016-00561
• Device Sequence Number: 866228
• Product Code: KWS
• UDI-Device Identifier: 00888867061019
• UDI-Public: 00888867061019
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2017

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 Catalogue Number: AR-9501-07CPC
• Device Lot Number: 150023110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2016
• Supplement Report FDA Received Date: 03/02/2017
• 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