MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROVISIONAL LINER 28 MM I.D. FOR USE WITH 44-49 MM O.D. SHELL; INSTRUMENT

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and 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: provisional liner part #00500305028, lot# 60012989: 0001822565-2019-01411.

Event Description

It was reported that this instrument broke.No known patient involvement.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Lot 62350241 was returned with locking assembled with the product and identified nicks and damages on it.The devices returned had potential field service ages from 5 years to 20 years.It is unknown how many times the devices were used.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to wear and tear of the devices.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.

• Brand Name: PROVISIONAL LINER 28 MM I.D. FOR USE WITH 44-49 MM O.D. SHELL
• Type of Device: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8485418
• MDR Text Key: 141019525
• Report Number: 0001822565-2019-01412
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• 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: 00500304428
• Device Lot Number: 62350241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1