MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Toxicity (2333)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.The returned ar-9503s-06 met all as-received specifications.This device was identified to be concomitant to the glenosphere.Visual evaluation revealed that a groove approximately 2.85mm deep was present along the rim of the cup.A witness mark consistent with damage caused during the removal process was observed to be present on the cup approximately 180° from the aforementioned groove.Some poly wear was noted upon inspection.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.
Event or Problem Description
It was reported by the sales rep that there was a revision of a right total shoulder case on (b)(6) 2018.The original date of surgery was (b)(6) 2015.The revision was due to limited range of motion and pain.Seven devices were removed from the patient; there was proximal metalosis in the shoulder joint and the glenosphere had disassociated from the baseplate.The following arthrex replacement devices were implanted: ar-9504l-04, univers reverse glenosphere, lot 170142415; ar-9502f-42cpc, univers reverse suturecup, lot 170117105; and ar-9503l-06, univers reverse humeral insert, lot 170170513.Additional information obtained (b)(6) 2018: sales rep has confirmed that his original report stating 7 devices were explanted was incorrect.Only the following three devices were explanted: ar-9503s-06 humeral insert (lot 2601221201), ar-9502-36cpc cup (lot 2501407907) and ar-9504s-04 glenosphere (lot 2501346003).All three devices are being returned to arthrex for evaluation.According to the medical records during the revision surgery the surgeon discovered the glenosphere to be completely disassociated from the baseplate.The surgeon also noted a significant amount of wear on the inferior aspect of the humeral poly insert.The glenosphere, humeral insert and humeral cup were removed.The surgeon assessed the baseplate and stem and decided that they were stable and not otherwise disrupted.The surgeon then decided to replace the worn components that were removed with new components and chose to increase the size of the glenosphere cup and insert from a 36 to a 42 for added stability.
Additional Manufacturer Narrative
Complaint confirmed.Returned ar-9503s-06 met all as-received specifications.Device was identified to be concomitant to the glenosphere.Visual evaluation revealed groove approximately 2.85mm deep present along the rim of cup.Witness mark consistent with damage caused during removal process was observed/present on cup approximately 180° from aforementioned groove.Some poly wear noted upon inspection.The glenosphere used for this surgery was not compatible with the baseplate.Arthrex¿s surgical technique guide provides a compatibility matrix which identifies the acceptable baseplate and glenosphere coupling and notes that the medium baseplate (ar-9120-02) is not compatible with a size 36 +4 glenosphere (ar-9504s-04).Arthrex¿s directions for use states that proper selection and placement of the implant are important considerations in the successful utilization of this device.Premature loosening and complications can occur with an unsuitable selection of the implant size.
Event or Problem Description
It was reported by the sales rep that there was a revision of a right total shoulder case on (b)(6) 2018.The original date of surgery was on (b)(6) 2015.The revision was due to limited range of motion and pain.Seven devices were removed from the patient; there was proximal metalosis in the shoulder joint and the glenosphere had disassociated from the baseplate.The following arthrex replacement devices were implanted: ar-9504l-04, univers reverse glenosphere, lot: 170142415; ar-9502f-42cpc, univers reverse suturecup, lot: 170117105; and ar-9503l-06, univers reverse humeral insert, lot: 170170513.Additional information obtained 11/8/2018: sales rep has confirmed that his original report stating 7 devices were explanted was incorrect.Only the following three devices were explanted: ar-9503s-06 humeral insert (lot: 2601221201), ar-9502-36cpc cup (lot: 2501407907) and ar-9504s-04 glenosphere (lot: 2501346003).All three devices are being returned to arthrex for evaluation.According to the medical records during the revision surgery the surgeon discovered the glenosphere to be completely disassociated from the baseplate.The surgeon also noted a significant amount of wear on the inferior aspect of the humeral poly insert.The glenosphere, humeral insert and humeral cup were removed.The surgeon assessed the baseplate and stem and decided that they were stable and not otherwise disrupted.The surgeon then decided to replace the worn components that were removed with new components and chose to increase the size of the glenosphere cup and insert from a 36 to a 42 for added stability.Additional information obtained 1/7/2019: upon further review of the medical records provided by the patient, the glenosphere used for this surgery was not compatible with the baseplate.Arthrex¿s surgical technique guide provides a compatibility matrix which identifies the acceptable baseplate and glenosphere coupling and notes that the medium baseplate (ar-9120-02) is not compatible with a size 36 +4 glenosphere (ar-9504s-04).Arthrex¿s directions for use states that proper selection and placement of the implant are important considerations in the successful utilization of this device and premature loosening and complications can occur with an unsuitable selection of the implant size.

• Brand Name: HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8129855
• Report Number: 1220246-2018-00777
• Device Sequence Number: 13515965
• Product Code: PHX
• UDI-Device Identifier: 00888867061316
• UDI-Public: 00888867061316
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 07/31/2017
• Device Model Number: HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP
• Device Catalogue Number: AR-9503S-06
• Device Lot Number: 2501221201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 03/06/2019
• 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: 78 YR
• Patient Weight: 70