MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY +5MM LNR 28MM A; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Device was returned with packaging damage and the sterility barrier potentially compromised.There is no additional information available.

Manufacturer Narrative

(b)(4).The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Visual examination of the returned product identified the outer box shows a hole in the side of box and damage to the lid on one side with the label that is torn.The box shows minimal damage to the tamper label side.The outer tyvek is damaged and cracked.The outer cavity has two cracks/punctures all the way through.Both tyvek lids are attached and show no signs of damage.The inner cavity is also not damaged.Sterility has not been compromised.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.The root cause of the reported event is likely to be due to transit damage 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: G7 LONGEVITY +5MM LNR 28MM A
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15265620
• MDR Text Key: 302066392
• Report Number: 0001822565-2022-02441
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024519466
• UDI-Public: (01)00889024519466(17)250531(10)64755668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

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: 20152801
• Device Lot Number: 64755668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1