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

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10173492
• Report Number: 0001825034-2020-02419
• Device Sequence Number: 19273021
• Product Code: PBI
• UDI-Device Identifier: 00880304526365
• UDI-Public: (01)00880304526365
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000850
• Device Lot Number: 6551483
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 86