MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERE RETENTIVE POLY LINER+6 MM 40 MM DIAMETER 65 DEGREE NECK; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Unstable (1667); Detachment of Device or Device Component (2907)

Patient Problem Joint Dislocation (2374)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Part # 00434903912, humeral stem space, lot # 64019204.Part # unk, glenosphere, lot # unk.Part # unk, humeral stem, lot # unk.Part # unk, augment, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-06783.

Event Description

It was reported that in an unknown timeframe post implantation, the patient underwent a revision of the liner and spacer due to disassociation, with recurrent instability and dislocation of the shoulder prosthesis.Attempts have been made and no further information has been provided.

Manufacturer Narrative

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 event information available at the time of this report.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of medical records and return of the devices.The liner and spacer were visually inspected.The poly liner exhibited wear and heavy gouges.Marks were observed inside the anti-rotation slot, which was consistent with impaction of the liner aligned to the spacer.Deformations were present around the perimeter of the distal face.Op notes from the revision noted that the polyethylene component had become somewhat disengaged from the humeral component and was rotated to 180 degrees.Device history record (dhr) was reviewed and no discrepancies were found.A definite root cause cannot be determined with the information 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: TM REVERE RETENTIVE POLY LINER+6 MM 40 MM DIAMETER 65 DEGREE NECK
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8153480
• MDR Text Key: 130074833
• Report Number: 0001822565-2018-06782
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00434906606
• Device Lot Number: 62651303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2019
• 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