MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN P-REF SIZER BOOM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Mechanical Problem (1384)

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

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2018-05569.Concomitant medical products: psn p-ref sizer, item# 42509904000, lot# 56575104.Foreign- events occurred in: (b)(6).Customer has indicated that the product will 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.

Event Description

It was reported that the posterior reference sizer¿s locking mechanism moves and unlocks when drilling the pilot holes to set the external rotation.No additional information is available at this time.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.The reported event was considered confirmed as visual examination of the returned product identified the p-ref sizer showed nicks and gouges indicative of repeated use.No visible signs of wear were noted on the teeth.Device history record (dhr) was reviewed for deviations and/ or anomalies with no relevant deviations / anomalies identified.Per the instrument/provisional use and care package insert, instruments should be carefully inspected before each use and should not be used if the instruments are marred or worn.A definitive root cause cannot 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: PSN P-REF SIZER BOOM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7948257
• MDR Text Key: 123806362
• Report Number: 0001822565-2018-05570
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 42509904010
• Device Lot Number: 63155484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 63 YR