MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number AR-9503S-06

Device Problems Break (1069); Positioning Problem (3009); Unintended Movement (3026)

Patient Problem Joint Dislocation (2374)

Event Date 05/01/2017

Event Type  Injury  

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 evaluation revealed that the humeral insert was damaged.The edge is broken, and severe gouge marks were observed on the articulating surface.The damages observed on the surfaces were most likely caused during the extraction of the implant.The contribution of the device to the reported event could not be determined.Device history record review revealed nothing relevant to this event.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 Description

It was reported that per the surgeon, the thickness of the trial does not match the thickness of the implant, ar-9503s-06 ((b)(4)).The fix was stable with the trial but not with the insert.They could not use the implant; they used a spacer and another poly to complete the reverse total shoulder.The cup, ar-9502f-36cpc ((b)(4)), could not screw into the stem (ar-9501-06cpc).Another cup was used with the same stem.This occurred outside the patient.A (b)(6) male.Additional information obtained 6/2/17: per sales rep, when they used the trial poly the shoulder was appropriately tensioned according to the surgeon.Therefore, the decision was made to open the same poly that they had trialed.Surgeon inserted the actual poly, ar-9503s-06 ((b)(4)) into the stem and reduced the shoulder.Upon reduction the surgeon said there was a significant difference in tension with the real poly vs the trial poly.The shoulder dislocated while running the arm through range of motion, which did not happen with the trial insert in.They then double checked the packaging to ensure that the poly that was opened was in fact the same size that had been trialed.Since the shoulder was so loose with the poly in, they had to remove the poly from the stem (causing the damage as seen on the returned device) and then had to open a thicker option to finish the case.Sales rep confirmed that the implant was returned damaged because it was inserted in the cup at one point and then removed which caused damage as visualized on the returned device.

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.The evaluation revealed that the humeral insert was damaged.The edge is broken, and severe gouge marks were observed on the articulating surface.The damages observed on the surfaces were most likely caused during the extraction of the implant.The contribution of the device to the reported event could not be determined.Device history record review revealed nothing relevant to this event.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 Description

It was reported that per the surgeon, the thickness of the trial does not match the thickness of the implant, ar-9503s-06 ((b)(4)).The fix was stable with the trial but not with the insert.They could not use the implant; they used a spacer and another poly to complete the reverse total shoulder.The cup, ar-9502f-36cpc ((b)(4)), could not screw into the stem (ar-9501-06cpc).Another cup was used with the same stem.This occurred outside the patient.(b)(6) year old male.Additional information obtained 06/02/2017: per sales rep, when they used the trial poly the shoulder was appropriately tensioned according to the surgeon.Therefore, the decision was made to open the same poly that they had trialed.Surgeon inserted the actual poly, ar-9503s-06 ((b)(4)) into the stem and reduced the shoulder.Upon reduction the surgeon said there was a significant difference in tension with the real poly vs the trial poly.The shoulder dislocated while running the arm through range of motion, which did not happen with the trial insert in.They then double checked the packaging to ensure that the poly that was opened was in fact the same size that had been trialed.Since the shoulder was so loose with the poly in, they had to remove the poly from the stem (causing the damage as seen on the returned device) and then had to open a thicker option to finish the case.Sales rep confirmed that the implant was returned damaged because it was inserted in the cup at one point and then removed which caused damage as visualized on the returned device.

• Brand Name: HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6661137
• MDR Text Key: 78183867
• Report Number: 1220246-2017-00230
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867061316
• UDI-Public: 00888867061316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: AR-9503S-06
• Device Lot Number: 160065609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AR-9502F-36CPC UNIVERSAL REVERSE SUTURE
• Patient Outcome(s): Other