MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unintended System Motion (1430)

Patient Problem Tissue Damage (2104)

Event Date 04/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown, humeral stem, unknown humeral tray, unknown glenoid.Unknown glenoid base plate.Dave r shukla, julia lee, devin mangold, robert h cofield, joaquin sanchez-sotelo, & john w sperling, (2018).Reverse shoulder arthroplasty with proximal humeral replacement for the management of massive proximal humeral bone loss.Journal of shoulder and elbow arthroplasty, volume 2: pg.1¿6.Doi: 10.1177/2471549218779845, journals.Sagepub.Com/home/sea.Reported event was unable to be confirmed.Dhr review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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 was reported in the journal article that scapular notching was noted in 3 patients: grade 2 in 2 patients and grade 3 in 1 patient.No additional information was provided.

Manufacturer Narrative

Root cause is related to patient condition.Per the author, "none of the complications or failures were due to problems inherent with the implants.They were due to patient co-morbidities and effects of having multiple prior procedures." 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 was reported in a journal article that scapular notching was noted in 3 patients: grade 2 in 2 patients and grade 3 in 1 patient post implantation.Attempts have been made and no further information has been provided.

• Brand Name: UNKNOWN HUMERAL BEARING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7743386
• MDR Text Key: 115830278
• Report Number: 0001825034-2018-05407
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other