MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HXPE LINER ELEVATED KK 36; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the sterile packaging was damaged.Additional information on the reported event is unavailable.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the provided pictures confirmed that the outer carton box is damaged at a corner and pierced through the representative image on the end panel label.The outer cavity is also pierced inward at a location that seems to correspond to the hole in the carton box.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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: HXPE LINER ELEVATED KK 36
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8949365
• MDR Text Key: 156456853
• Report Number: 0001822565-2019-03643
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024149786
• UDI-Public: (01)00889024149786
• Combination Product (y/n): N
• PMA/PMN Number: K123019
• 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: 11/20/2019

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 Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00875201236
• Device Lot Number: 63830355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1