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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.It is unknown which screw fractured from the list of screws in concomitant products.It could be one of the following: comprehensive locking screw 3.5 hex 4.75mmx20mm, item #: 180551, lot #: 115140, manufacture date: 16 feb.2016; sterile expiration date: 16 feb.2026.Comprehensive locking screw 3.5 hex 4.75mmx25mm, item #: 180552, lot #: 542240, manufacture date: 28 dec.2015; sterile expiration date: 28 dec.2025.Comprehensive locking screw 3.5 hex 4.75mmx20mm, item #: 180551, lot #: 889990, manufacture date: 28 oct.2015; sterile expiration date: 28 oct.2025.Comprehensive locking screw 3.5 hex 4.75mmx40mm, item #: 180555, lot #: 474300, manufacture date: 05 sep.2014; sterile expiration date: 30 sep.2024.Concomitant medical product: comprehensive reverse central 6.5mmx30mm screw, catalog #: 115396 , lot #: 583310; comprehensive locking screw 3.5 hex 4.75mmx20mm, catalog #: 180551, lot #: 115140; comprehensive locking screw 3.5 hex 4.75mmx25mm, catalog #: 180552, lot #: 542240; comprehensive locking screw 3.5 hex 4.75mmx20mm, catalog #: 180551, lot #: 889990; comprehensive locking screw 3.5 hex 4.75mmx40mm, catalog #: 180555, lot #: 474300; comprehensive reverse glenosphere, catalog #: 115310, lot #: 528420; comprehensive reverse primary stem, catalog #: 113648, lot #: 075520; comprehensive arcom humeral bearing, catalog #: xl-115363, lot #: 922440; comprehensive reverse humeral tray, catalog #: 115370, lot #: 561910; comprehensive reverse baseplate size 25mm with taper adapter, catalog #: 010000589, lot #: 357470.Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2016-05477).

Event Description

It was reported the patient underwent a right total shoulder revision due to loosening of the baseplate, screw breakage, and bone loss.All products were removed at the time of the revision.It was noted that during the revision procedure, the surgeon had to burr bone away superiorly because the computed tomography scatter was mistaken for bone loss when the bone was actually present.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.X-ray reviewer stated: "reverse shoulder arthroplasty exhibiting loosening of glenoid component, broken glenoid component screw and grade 4 scapular notching.Relatively high position of the baseplate and superior tilt of the baseplate are factors identified which increase risk of scapular notching and mechanical loosening of the glenoid component." device history record (dhr) for all 4 possible part and lot combinations for the screw was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.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: UNKNOWN COMPREHENSIVE REVERSE SCREW
• 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: 6543387
• MDR Text Key: 74363606
• Report Number: 0001825034-2017-03061
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 68 YR