MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 6 MM OFFSET 36 MM DIAMETER; PROSTHESIS, EXTREMITIES

Catalog Number 00434903606

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

It was reported that the internal packaging was damaged, sterility was compromised.No patient involvement.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause of the reported issue 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. .

Event Description

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

• Brand Name: POLY LINER PLUS 6 MM OFFSET 36 MM DIAMETER
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10355822
• MDR Text Key: 202698837
• Report Number: 0001822565-2020-02754
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024269071
• UDI-Public: (01)00889024269071
• Combination Product (y/n): N
• PMA/PMN Number: K130661
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00434903606
• Device Lot Number: 64008396
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1