MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMORAL CR IMPACTOR PAD; INSTRUMENT, KNEE

Model Number N/A

Device Problems Fracture (1260); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 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.

Event Description

It is reported that the impactor pad fractured upon impaction during right knee arthroplasty.No adverse events were reported as a result of this event.

Manufacturer Narrative

The complaint sample was evaluated and the reported event was confirmed through physical evaluation.The returned impactor pad showed signs of repeated use (nicked or gouged) and was confirmed to be fractured off from the center.The device history records were reviewed and no discrepancies were identified.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.

• Brand Name: PERSONA FEMORAL CR IMPACTOR PAD
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7771883
• MDR Text Key: 116717400
• Report Number: 0001822565-2018-04291
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK172524
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• 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: 42509909400
• Device Lot Number: 62305405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 102