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

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

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Rangarajan, rajesh md, blout, collin k.Bs, patel, vikas v.Md.(2020).Early results of reverse total shoulder arthroplasty using a patient-matched glenoid implant for severe glenoid bone deficiency.Journal of shoulder and elbow surgery, 29, 139-148.Https://doi.Org/10.1016/j.Jse.2020.04.024.Concomitant medical products: unknown vrs cat#ni lot#ni.Unknown comprehensive reverse humeral stem cat#ni lot#ni.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 mdrs are associated with this report; please see associated reports: 0001825034 - 2021 - 00277, 0001825034 - 2021 - 00279.

Event Description

It was reported in a journal article retrieved from the journal of shoulder and elbow surgery (2020), which studied patients who underwent rtsa using vrs, that one patient with chronic hepatitis c presented to a local hospital with an infected prosthesis eroding through the skin.He underwent emergent component removal, irrigation and debridement, and antibiotic spacer placement less than 3 months after the surgical procedure and was lost to follow-up.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

B1 correction: this event was originally reported as both a serious injury and malfunction.It was found to be serious injury only.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: 11244432
• MDR Text Key: 229165948
• Report Number: 0001825034-2021-00278
• Device Sequence Number: 1
• Product Code: PHX
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention