MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 15MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Death (1802); Unspecified Infection (1930)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 010000662 g7 pps ltd acet shell 50d lot# 6289152, item# 010000856 g7 neutral e1 liner 36mm d lot# 6289818, item# 51-130100 tprlc 133 fp 12/14 bm so 10.0 lot# 6246373, item# 010000998 g7 screw 6.5mm x 25mm lot# 6238952, item#650-0836 bioloxdeltamodularceramichead 32mm-4mmneck, type12/14taper lot# 2018012043.Report source: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01365, 0001825034 - 2019 - 01364, 0001825034 - 2019 - 01363, 0001825034 - 2019 - 01362.

Event Description

It was reported that patient underwent a hip arthroplasty revision due to infection approximately 9 months post initial implantation.Patient was reportedly treated with multiple washouts and antibiotic treatments without success, prior to explantation of the implants.Patient subsequently passed away a few days after the revision procedure due to the infection.

Manufacturer Narrative

(b)(4).Surgeon notes there was a wound dehiscence occurred at some point.There was washouts (i&ds) performed & antibiotic treatments given till revision was done.Infection (klebsiella) was cultured from the acetabulum only.Infection occurred within 1 yr post procedure.Klebisella is a known bacteria to be related to joint infections, as well as pneumonia, urinary tract infections and blood infections.It is unknown if the patient had an existing infection while the initial procedure was performed, which could be a contributing factor as well as patient was noted to be morbid obese, which increases the risk for infections post op.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 SCREW 6.5MM X 15MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8459378
• MDR Text Key: 140138837
• Report Number: 0001825034-2019-01367
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• 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: 010000996
• Device Lot Number: 3716836
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention