MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM 48 DEGREES 13 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, EXTREMITIES

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Pain (1994)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: event occurred in (b)(6).Concomitant medical products: item# unknown; unknown tm glenoid; lot# unknown, item# unknown; unknown humeral head; lot# unknown.The product will not be returned to zimmer biomet for investigation.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: 0001822565-2019-04747.Product not returned.

Event Description

It was reported that the patient has underwent an initial shoulder arthroplasty.Subsequently, the patient was revised due to pain and wear of the glenoid component.It was further reported that tantalum debris was evident on scans.No additional patient consequences were reported.

Event Description

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.The initial report was forwarded in error and should be voided.

• Brand Name: HUMERAL STEM 48 DEGREES 13 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9311410
• MDR Text Key: 166316452
• Report Number: 0001822565-2019-04741
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K041549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

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
• Device Expiration Date: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00434811313
• Device Lot Number: 60748332
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 12/06/2019
• 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
• Patient Weight: 120