MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS TRAY CO 44MM; PROSTHESIS, EXTREMITIES

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown insert.Report source: (b)(6).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: 0001825034-2019-05150.

Event Description

It was reported that during surgery the surgeon had problems fitting the polyethylene insert into the humeral plate.After multiple attempts the insert was hammered inside so that the products fit together.No further information is available at this time.

Event Description

No additional information reported.

Manufacturer Narrative

Reported event could not be confirmed; visual and dimensional evaluations could not be performed as no product was returned or pictures provided.Review of the device history records identified no deviations or anomalies during manufacturing of tray related to the reported event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP RVS TRAY CO 44MM
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9376762
• MDR Text Key: 201046563
• Report Number: 0001825034-2019-05148
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304543201
• UDI-Public: (01)00880304543201
• Combination Product (y/n): N
• PMA/PMN Number: K113069
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115370
• Device Lot Number: 161290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1