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

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Information (3190)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 there was hair found on the sterile package of insert package.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Manufacturer Narrative

(b)(4).Implant date - implant date was initially reported on the initial medwatch; however, that date was entered in error.The field should be blank as it was confirmed this product was not implanted.Report source foreign - (b)(6).Complaint sample was evaluated and the reported event was not confirmed.Visual evaluation of the returned product could not identify any debris/hair in the package.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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 JJ 36
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8764818
• MDR Text Key: 150156047
• Report Number: 0001822565-2019-02826
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K123019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00875201136
• Device Lot Number: 64166336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1