MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET MODULAR HUMERAL HEAD 23 MM HEAD HEIGHT; PROSTHESIS SHOULDER

Model Number N/A

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: catalog #: 00434903700, dual taper insert, lot # 63342725.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00322.Revision hasn't occured yet.

Event Description

It was reported that this is the patient's second revision that will occur on an unknown date due to pain and loss of function.No additional information is available at this time.

Manufacturer Narrative

(b)(4).Updated: b4, b5, d4 (udi), e1, g4, h1, h2, h3, h6, and h10 reported event was considered confirmed as the x-rays noted the glenoid component of the scapula is suboptimally characterized secondary to superimposition of hardware-related to the humeral head.No other issues were noted.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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 available at the time of this report.

• Brand Name: OFFSET MODULAR HUMERAL HEAD 23 MM HEAD HEIGHT
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9633293
• MDR Text Key: 176555573
• Report Number: 0001822565-2020-00321
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00430204623
• Device Lot Number: 63180529
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention