MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Erosion (1750); Pain (1994)

Event Date 10/09/2012

Event Type  Injury  

Manufacturer Narrative

(b)(6).Concomitant medical product: comprehensive shoulder system primary mini shoulder stem, catalog#: 113630, lot#: 199270; comprehensive reverse shoulder humeral tray with locking ring, catalog#: 115340, lot#: 340620; comprehensive reverse shoulder humeral bearing, catalog#: xl-115363, lot#: 205480; comprehensive reverse shoulder glenosphere, catalog#: 115310, lot#: 258650; comprehensive reverse shoulder glenosphere baseplate, catalog#: 115330, lot#: 777340; comprehensive reverse shoulder central screw, catalog#: 115381, lot#: 254110; fixed locking screw, catalog#: 180500, lot#: 203120; fixed locking screw, catalog#: 180501, lot#: 730560.Customer has indicated that device will not return, as it is still implanted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05026, 05030, 05235.Reported event was unable to be confirmed due to limited information received from the customer.X-ray review stated "high position of the glenoid component baseplate and large humeral component are both factors which increased risk of impingement, scapular notching and mechanical loosening.Grade 1 scapular notching at the inferior pillar of the scapular neck.Large humeral tray may also result in overstuffing of the glenohumeral joint, increasing capsular tension, limiting range of motion and possibly contributing to pectoralis "pulling sensation".Glenosphere is not circumferentially seated on the base plate, consistent with disengagement.Radiolucency at humeral tray metal- bone interface may be indicative of the humeral component loosening if new or progressive." device history record (dhr) 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.

Event Description

It is reported that the patient underwent reverse shoulder arthroplasty, and 1 year later experienced a pulling sensation in the anterior aspect of her pectoral muscle 3 weeks following onset.The issue has since resolved, and the surgeon does not plan to revise.Review of patient's post-operative radiographs found the glenosphere not fully seated on the baseplate, consistent with disengagement; scapular notching; and radiolucency at the humeral tray-bone interface.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.X-ray review stated "high position of the glenoid component baseplate and large humeral component are both factors which increased risk of impingement, scapular notching and mechanical loosening.Grade 1 scapular notching at the inferior pillar of the scapular neck.Large humeral tray may also result in overstuffing of the glenohumeral joint, increasing capsular tension, limiting range of motion and possibly contributing to pectoralis "pulling sensation".Glenosphere is not circumferentially seated on the base plate, consistent with disengagement.Radiolucency at humeral tray metal- bone interface may be indicative of the humeral component loosening if new or progressive." device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.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: VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR
• 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: 6746807
• MDR Text Key: 81152016
• Report Number: 0001825034-2017-05235
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 383930
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2011
• 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): Other
• Patient Age: 78 YR
• Patient Weight: 71