MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE GLENOSPHERE; PROSHTESIS, SHOULDER

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Muscle/Tendon Damage (4532)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was disposed of by the hospital.Concomitant medical devices: item number: ep-115393, item name: standard humeral bearing, lot number: 100560; item number: 118001, item name: versa-dial comprehensive standard taper, lot number: 520020; item number: 115370, item name: comprehensive reverse tray, lot number: 612230.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03979.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a shoulder revision approximately 5 years post-implantation due to pain, instability and recurrent dislocation.During the revision, it was noted that the subscapularis tendon of the rotator cuff was disrupted.The humeral stem and glenoid were well-fixed and left intact.All other components were replaced without complication.

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records identified the following: initial implantation, patient required a 2 week stay at the rehabilitation hospital because of lack of independence from his right hemiplegia which was pre-existing.No pain was indicated.Patient indicated that he was rolling over in bed and when he attempted to get up his shoulder dislocated anteriorly.Closed reduction was performed in the er.X-ray review found satisfactory position of alignment of the total shoulder reverse.Patient later underwent revision surgery.Disruption of the subscapularis tendon in the lower 2/3 was found.Components were exchanged without complication or further significant findings.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE REVERSE GLENOSPHERE
• Type of Device: PROSHTESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10801582
• MDR Text Key: 215059130
• Report Number: 0001825034-2020-03980
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 597560
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• 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: 69 YR
• Patient Weight: 94