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

Catalog Number 115310

Device Problem Malposition of Device (2616)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Swelling (2091)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).Medical product - biomet comprehensive humeral tray with locking ring catalog#: 115370 lot #:910020, biomet comprehensive mini humeral stem catalog #113630 lot#836390, biomet humeral bearing catalog # xl-115363 lot#502530.This report is number 5 of 5 mdrs filed for the same patient (reference 1825034-2016-03745 / 03746 / 03747, 05210, 05226).

Event Description

Patient underwent a right shoulder revision procedure approximately four months post-implantation due to alleged pain, swelling, loose screws, and bone fracture.

Manufacturer Narrative

Reported event was confirmed by review of the provided op notes and x-rays.Per the revision operative notes, the patient had mechanical failure with severe bone loss.The glenosphere and baseplate were loose with a large defect.Per the ct scan results, there was superior displacement of the scapular component with associated 18mm bony fragment suggestive of a moderately displaced fracture from the anterior aspect of the glenoid and scapular spine.There appears to be a nondisplaced fracture through the base of the coracoid process as well.Per the x-ray review, "complaint suggests loosening of all the screws.This could be identified radiographically as periprosthetic lucencies surrounding the screws.The only images that show the screws are 1, 2, and 5.None of these images reveal this to be confirmed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6216027
• MDR Text Key: 63661616
• Report Number: 0001825034-2016-05226
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2016
• Device Catalogue Number: 115310
• Device Lot Number: 123990
• Other Device ID Number: REFERENCE H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR