MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM 18 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 04/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 00434906503, retentive poly liner plus, lot # 63500073.Catalog #: 47430902501, pin 2.5 mm diameter, lot # 64525873.Catalog #: 00436202000, base plate uncemented, lot # 64475667.Catalog #: 0104223036, anatomical shoulderâ¿¢ reverse, lot # 2985531.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial total shoulder procedure approximately two (2) and a half years ago.Subsequently, the patient underwent a revision due to wear about two (2) months ago (covered under a different complaint).Then underwent a 2nd revision a week ago due to poly disassociating from stem from picking up his dog.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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 18 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: 10079411
• MDR Text Key: 191712231
• Report Number: 0001822565-2020-01637
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024269187
• UDI-Public: (01)00889024269187
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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: 00434901813
• Device Lot Number: 63102455
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2020
• 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