MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM 16 MM STEM DIAMETER 130 MM STEM LENGTH STERILE; PROSTHESIS SHOULDER

Model Number N/A

Device Problems Material Erosion (1214); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: catalog #: 00434906506, retentive poly liner, lot # 64333472; catalog #: 115313, comp rvsr shldr glnsp, lot # 612700; catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr r, lot # 005110.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02726 and 0001822565-2020-02727.Discarded.

Event Description

It was reported that the patient underwent a total shoulder procedure approximately 5 months ago.Subsequently the patient was revised one month later due to poly disassociation.Patient was revised again 3 months later due to disassociation and impingement.Wear on the interior of the stem and calcar was noted.Attempts have been made and there is no additional information available at this time.

Manufacturer Narrative

(b)(4) updated: b4, b5, d4 (udi), g4, h1, h2, h3, h6, h10.Reported event was confirmed per the review of the x-rays, which identified superior dislocation of the humeral component and now abutment of the glenosphere and the calcar with associated bony resorption.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: HUMERAL STEM 16 MM STEM DIAMETER 130 MM STEM LENGTH STERILE
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10344384
• MDR Text Key: 201352745
• Report Number: 0001822565-2020-02724
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• 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: 00434901613
• Device Lot Number: 64448713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2020
• 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