MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 03/15/2022

Event Type  Injury  

Event Description

It was reported that patient underwent a hip revision approximately 1.5 years post implantation due to thigh pain and instability.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Implanted in (b)(6) 2020.Concomitant medical products: 51-130110 ¿ taperloc stem ¿ 6616845.Unknown cup ¿ unknown part and lot.Unknown biolox head ¿ lot 3108029.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the hospital did not approve of the return.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 information.A review of the available records identified findings of the reported issues thigh pain and instability as reported.A review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

• Brand Name: G7 NEUTRAL E1 LINER 36MM 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: 14073476
• MDR Text Key: 288986382
• Report Number: 0001825034-2022-00847
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526433
• UDI-Public: (01)00880304526433(17)240907(10)6623250
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• 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: 010000858
• Device Lot Number: 6623250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2019
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male