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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unk comprehensive reverse humeral stem cat#ni lot#ni, unk comprehensive reverse glenosphere cat#ni lot#ni, unk comprehensive reverse baseplate cat#ni lot#ni, unk comprehensive reverse humeral bearing cat#ni lot#ni.Acott, thomas r.Md, brolin, tyler j.Md, azar, frederick m.Md.(2020).A quantitative analysis of deltoid lengthening and deltoid-related complications after reverse total shoulder arthroplasty: a retrospective case-control study.Current orthopaedic practice, 31(2), 126-132.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: 0001825034-2021-00236, 0001825034-2021-00237, 0001825034-2021-00238, 0001825034-2021-00239.

Event Description

It was reported in a journal article from current orthopaedic practice (2020), which reviewed deltoid complications after rtsa, that 4 patients experienced persistent deltoid pain with or without tightness later than 2 years after surgery.Patients were noted to have significantly more deltoid lengthening than patients in the control group at 26.3mm (range 17.6-35.6).2 patients complained of persistent deltoid pain and tightness.There were no subsequent surgeries or further complications in these patients.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

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.

• Brand Name: UNK COMPREHENSIVE REVERSE TRAY
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11236189
• MDR Text Key: 232099232
• Report Number: 0001825034-2021-00240
• Device Sequence Number: 1
• Product Code: HSD
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• 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: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other