MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PT HYBRID GLEN POST REGENEREX; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Debris, Bone Shedding (1803)

Event Date 09/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 02344.

Event Description

It was reported patient went under a revision procedure six (6) years post-implantation due to bone erosion and wear of glenoid with loss of function.Operative reports indicate that during the revision procedure, the surgeon noted large amounts of scar tissue that was removed, fibrous membrane removed from the entire aspect of the glenoid medially beyond coracoid, fibrous material removed from the subscapularis and remnant of where the supraspinatus had been; which was basically atrophic.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional and confirmed the reported erosion and wear of glenoid.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: limited examination.Possible periprosthetic lucency surrounding the glenoid screw cannot be confirmed.If there is wear of the glenoid component not related to the actual metallic component (polyethylene), this would not be appropriately evaluated radiographically as polyethylene is radiolucent and not well depicted radiographically.Possible narrowing of the glenohumeral joint space is described which is a secondary sign of possible polyethylene wear of the glenoid component.A definitive root cause cannot be determined.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

No further information available at the time of this reporting.

• Brand Name: PT HYBRID GLEN POST REGENEREX
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8647922
• MDR Text Key: 146329918
• Report Number: 0001825034-2019-02343
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K060694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: N/A
• Device Catalogue Number: PT-113950
• Device Lot Number: 981930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 113063, HEAD, 399380; 113633, STEM, 795580; 113956, GLENOID, 688380; 118001, TAPER, 221400; UNKNOWN COBALT BONE CEMENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 84