MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FREEDOM CONST E1 LNR 36MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Loss of Range of Motion (2032)

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cat#: 110010266, g7 osseoti multihole 56mm f, lot#: 6975783.Cat#: 51-113140, tprlc 133 type1 bm so 14.0, lot#: 6685962.Foreign country: (b)(6).The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01246.

Event Description

It was reported a patient underwent a hip arthroplasty.Subsequently, the patient was revised approximately nine (9) months later due to lack of range of motion.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.The provided x-ray does not help or enhance the investigation.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.

Event Description

No further event information available at the time of this report.

• Brand Name: G7 FREEDOM CONST E1 LNR 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: 14460983
• MDR Text Key: 292350783
• Report Number: 0001825034-2022-01245
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304989085
• UDI-Public: (01)00880304989085(17)250310(10)6760382
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 010000984
• Device Lot Number: 6760382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male