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

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4.) concomitant medical products: unk comprehensive reverse humeral stem cat#ni lot#ni.Unk comprehensive reverse baseplate cat#ni lot#ni.Unk comprehensive reverse bearing cat#ni lot#ni.Unk comprehensive reverse tray cat#ni lot#ni.Hartline, jacob t., brolin, tyler j., wan, jim y.(2020).The effect of subscapularis management technique on outcomes and complication rates following reverse total shoulder arthroplasty.Seminars in arthroplasty (30), 42-49.Https://doi.Org/10.1053/j.Sart.2020.04.005 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00221 ,0001825034 -2021 - 00223 0001825034 - 2021 - 00224, 0001825034 - 2021 - 00225.

Event Description

It was reported in a journal article from seminars in anthoplasty: jses (2020), which studied the effect of various subscapularis tendon management techniques following an rtsa, that 1 patient within the no repair repair group experienced unknown complications.No interventions or further treatments were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.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 event information is available at the time of this report.

• Brand Name: UNK COMPREHENSIVE REVERSE GLENOSPHERE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11233242
• MDR Text Key: 228834972
• Report Number: 0001825034-2021-00222
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other