MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 44MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Metal Related Pathology (4530)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Source: (b)(4).Catalog number: 00801802802 lot number:63916779 brand name: (b)(6).Catalog number:00811400200 lot number:64046654 brand name: (b)(6).Catalog number:ep-200150 lot number:211640 brand name: (b)(6).Catalog number:010000665 lot number: 6378239 brand name: (b)(6).Catalog number:110024464 lot number: 857020 brand name: (b)(6).Multiple reports were submitted along with this report 0001825034-2022-00899.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

It was reported that the patient experienced elevated metal ion levels approximately 2 years post implantation.However, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, it was determined that the event is not reportable as there was an error in hospital reporting, and the metal levels were not elevated.Additional information received indicated that the hospital lab initially reported the cobalt levels in the unit nmol/l, instead of ug/l.Correct conversions found that the patient did not have elevated cobalt levels.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that the event is not reportable as there was an error in hospital reporting, and the metal levels were not elevated.Additional information received indicated that the hospital lab initially reported the cobalt levels in the unit nmol/l, instead of ug/l.Correct conversions found that the patient did not have elevated cobalt levels.

• Brand Name: G7 DUAL MOBILITY LINER 44MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14148378
• MDR Text Key: 289668027
• Report Number: 0001825034-2022-00900
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110024464
• Device Lot Number: 857020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Female