MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM 12 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, SHOULDER

Catalog Number 00434901213

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

Patient Problems Pain (1994); Swelling (2091); Thrombus (2101)

Event Date 07/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ti-115313 comp vrsdl glnspr 36mm +3 ti 465130, 010000589 comp rvrs 25mm bsplt ha+adptr 790090, 115395 comp rvs cntrl 6.5x25mm st/rst 515010, 180551 comp lk scr 3.5hex 4.75x20 st ni, 180551 comp lk scr 3.5hex 4.75x20 st 005100, 180550 comp lk scr 3.5hex 4.75x15 st 871370, 180552 comp lk scr 3.5hex 4.75x25 st ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It has been reported patient underwent a primary right reverse total shoulder arthroplasty.Subsequently, one week post-implantation, patient was doing pt at home when she felt her arm tighten up and start to swell.Patient then had an er visit complaining of arm pain, redness and swelling above the elbow.Ultrasound revealed superficial thrombus is cephalic vein.Treated with warm compressed and discharged home without admission.No device revision or removal.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Dhr was not reviewed because the issue was found to not be device-related.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Deep vein thrombosis, or dvt, occurs when a blood clot forms in one of the deep veins of the body.Blood clots can also occur in superficial veins, or veins closer to the surface of the skin.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operative for a period of time to prevent the development of dvt/blood clot.Even with the adminstration of preventive medication, dvt/blood clots can still develop.As the complaint indicated a post-operative complication developed and a visit to the emergency room was required to treat the complication, therefore our complaint category, medical: procedure related would be appropriate.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 available at the time of this report.

• Brand Name: HUMERAL STEM 12 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9912562
• MDR Text Key: 186757429
• Report Number: 0001822565-2020-01183
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024268951
• UDI-Public: (01)00889024268951
• Combination Product (y/n): N
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00434901213
• Device Lot Number: 63257359
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 73