MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK COMPREHENSIVE REVERSE SHOULDER POLY; EXTREMITY IMPLANT

Model Number N/A

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

Patient Problem Hematoma (1884)

Event Date 10/16/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign source: uk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a journal article was retrieved from journal of shoulder and elbow arthroplasty (2022) that reported a retrospective study from the united kingdom that looked at reverse total shoulder arthroplasties (rtsa) performed october 2010 ¿ october 2016.The purpose of the study was to compare the clinical outcomes of primary reverse total shoulder arthroplasty using patient-specific instrumentation (psi) versus the standard methods.The study reported one patient developed a postoperative extensive hematoma collection in the second week requiring a surgical evacuation and polyethylene insert change.The patient continued follow up with no further complications reported.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).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 further reported that a study reported one patient underwent a reverse total shoulder replacement approximately 11 year ago.Post-operatively, was placed on a fragmin due to having a prior metallic valve replacement.Subsequently, one week later, developed an extensive hematoma collection.About a week later, the patient underwent a washout and exchange of the polyethylene insert.The patient continued to follow up without complications.

Event Description

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

Manufacturer Narrative

(b)(4).A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure.The development of a postoperative hematoma after a procedure can be correlated with the surgical procedure and perioperative anticoagulation therapy to prevent dvt (prophylaxis).Patients may be at increased risk for developing hematomas if they have received fresh-frozen plasma, vitamin k, or hormonal therapy as well.Most hematomas resolve on their own, without surgical intervention, while some others do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.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.H3 other text : not returned.

• Brand Name: UNK COMPREHENSIVE REVERSE SHOULDER POLY
• Type of Device: EXTREMITY IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15598969
• MDR Text Key: 301721728
• Report Number: 0001822565-2022-02963
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization