MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ARCOMXL; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Tissue Damage (2104)

Event Date 10/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Concomitant medical products-baseplate catalog#:010000589 lot#:184750, locking screw catalog#:180550 lot#:808790, screw catalog#:180560 lot#:119660, bearing catalog#:xl-115363 lot#:169800, screw catalog#:115396 lot#:399510.The device has been received by zimmer biomet (b)(4) for evaluation.Once the investigation is complete, a follow-up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02775, 0001825034-2017-04973, 0001825034-2017-04976, 0001825034-2017-04977,0001825034-2017-04979.

Event Description

It is reported the patient underwent a right total shoulder arthroplasty revision approximately four months post-implantation due to disassociation of the taper from the baseplate.Additional information received in revision operative notes, also notes the patient was experiencing pain and a grinding sensation prior to revision.During the revision, significant liner erosion was noted, and the baseplate was found to be loose, with marked glenoid bone deficiency.All components, except the humeral stem, were removed and replaced.

Manufacturer Narrative

The following report is submitted to relay additional information.The reported event is confirmed with review of the provided surgical notes as well as the returned products.Visual examination showed gouges, nicks and excessive wear.This visual abrasion confirms the migration of the glenosphere, which is evidence of disassociation.Among the returned items was a screw not compatible with the other implants; while this could have been a contributing factor it cannot be confirmed whether this screw was used in the primary procedure.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ARCOMXL
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6715197
• MDR Text Key: 80089617
• Report Number: 0001825034-2017-04978
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/16/2021
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 169800
• Other Device ID Number: REFERENCE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 66