MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 32MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Post Operative Wound Infection (2446)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Year of birth: 1945.Concomitant medical products: 51-103110 6623525 tprlc 133 t1 pps so 11x142mm.650-1163 2019090117 delta cer fem hd 32/-3mm t1 m t1.110017333 6542036 g7 bispherical shell 54f.Foreign report source: (b)(6).Reported event was confirmed by review of medical records received.Medical notes were reviewed and identified patient was admitted to the hospital for suspected wound infection.However, patient hospitalized for 4 days, lab results dropped spontaneously without treatment, discharged and outpatient check 1 week after and no indications of infection were evidence from the reports.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00796.

Event Description

It was reported patient underwent initial right total hip arthroplasty performed.The patient subsequently underwent revision of the head and liner approximately three weeks post implantation due to a periprosthetic fracture.The patient was admitted to the hospital approximately one month post revision for suspected wound infection, symptoms unknown.During the course of the hospital stay, the patient¿s labs normalized without treatment or intervention.The patient was discharged with follow up scheduled.Additional information on the reported event is unavailable.

• Brand Name: G7 NEUTRAL E1 LINER 32MM 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: 10173492
• MDR Text Key: 196426784
• Report Number: 0001825034-2020-02419
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526365
• UDI-Public: (01)00880304526365
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000850
• Device Lot Number: 6551483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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
• Patient Outcome(s): Hospitalization
• Patient Weight: 86