MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 15MM MICRO; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The taper is packaged with the baseplate, part 010000589, lot 193690.The baseplate was not revised during this event.(b)(4).Concomitant medical products: 010000589, comp rvrs 25mm bsplt ha+adptr, lot 193690, ep-115396, humeral bearing, lot 902720, 180550, locking screw, lot 430410 (quantity 2), 115388, central screw, lot 988270, 180554, locking screw, lot 802350, 115323, glenosphere, lot 351390, 115370, tray, lot 838650, 115385.Central screw, lot 721600.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 00433.

Event Description

It was reported that approximately 7 weeks post implantation, the patient was revised of the mini taper adaptor and stem due to disengagement of the taper from the baseplate.Attempts have been made and no further information has been provided.

Manufacturer Narrative

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

Event Description

No further event information available at the time of this report.

• Brand Name: COMP PRIMARY STEM 15MM MICRO
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8307089
• MDR Text Key: 135064798
• Report Number: 0001825034-2019-00434
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• 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: 113615
• Device Lot Number: 086060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR