MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVS HMRL TI TRAY 44MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Unstable (1667)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, it states, ¿improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.¿ this report is number 1 of 2 mdr's filed for the same event (reference 1825034-2015-04452 and 04453).

Event Description

It was reported that patient underwent right total reverse shoulder arthroplasty in (b)(6) 2009.Subsequently, patient underwent a revision procedure on (b)(6) 2015 due to implant fracture.Patient reported a hearing a pop several months prior to the revision.During the revision, while implanting the humeral tray, the surgeon felt the tray was not stable and removed the tray and replaced with another humeral tray.The bearing was also removed and replaced.

Manufacturer Narrative

The follow up report is submitted to relay additional information received.The complaint is confirmed based on the photos that were provided.X-ray was received and reviewed.Per the review, "overall size of the hardware is appropriate.There does appear to be a fracture involving the humeral baseplate from the humeral stem without dislocation.Osteopenia is present.No indications of subsidence, poly wear debris, subluxation, corrosion, osteolysis." review of device history records found these units were released to distribution with no deviations or anomalies.Root cause of the tray fracture is related to design deficiency.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.

Manufacturer Narrative

The following report is submitted to relay additional information received: concomitant medical products : crs central screw ¿ cat.No.115383, lot no.245440 ; crs glenosphere ¿ cat.No.115320, lot no.742540 ; crs glenosphere ¿ cat.No.115330, lot no.256930 ; fixed locking screw ¿ cat.No.180500, lot no.029310; fixed locking screw ¿ cat.No.180501, lot no.851420; fixed locking screw ¿ cat.No.180504, lot no.851970 ; fixed locking screw ¿ cat.No.180503, lot no.257240 ; crs humeral bearing ¿ cat.No.Xl-115366, lot no.469720; crs stem ¿ cat.No.113633, lot no.748600 ; crs standard adapter ¿ cat.No.118001, lot no.414650.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of medical records noted that the patient fell on his right shoulder 5 months prior to revision which could be a contributing factor to the implant fracture.

Event Description

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

• Brand Name: COMP RVS HMRL TI TRAY 44MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 5190166
• MDR Text Key: 29921326
• Report Number: 0001825034-2015-04452
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 659970
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1103-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR