MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY NEUTRAL 36MM D; PROTHESIS, HIPS

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported debris was found on the implant.The debris was surface level and was able to be wiped away with mild effort.No patient involvement reported.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not 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

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated.No product was returned.Visual evaluation of the provided photos found unknown black debris on the surface of the device.Feedback from the customer noted the debris was able to be wiped away with mild effort.As the product was previously opened, the source of the debris cannot be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for the reported part and part lot combinations.Medical records were not provided.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was previously opened.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 LONGEVITY NEUTRAL 36MM D
• Type of Device: PROTHESIS, HIPS
• 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: 18838224
• MDR Text Key: 336998557
• Report Number: 0001822565-2024-00771
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024518735
• UDI-Public: (01)00889024518735(17)281022(10)66338754
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 20103604
• Device Lot Number: 66338754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2023
• 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