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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 05/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to unknown product location.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Medical devices: 010000665, g7 pps ltd acet shell 56f, 6229129; 193011, echo b-mtrc mp fp so 11, 551060; 650-1057, cer bioloxd option hd 36mm, 2907284.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04753; 0001825034 - 2018 - 04755; 0001825034 - 2018 - 04756.

Event Description

It was reported patient underwent an initial left hip procedure.Patient then reported an acute onset of progressive pain and swelling for 6 days following a gastrointestinal illness approximately a month and a half post surgery.Subsequently, patient underwent a hip revision surgery due to pain, swelling, and infection less than 2 months post implantation.During the revision procedure, the patient experienced an estimated blood loss of 800mls and required a packed red blood cell transfusion.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Concomitant medical products: item# (b)(4), item name: cer option type 1 tpr sleve +3, lot# unknown.Reported event was confirmed by review of medical records which state that the patient underwent explant of the total hip with placement of an antibiotic-coated articulating spacer due to infection.Estimated blood loss 800ml and packed red blood cell transfusion.Returned components were evaluated and found conforming to print specifications.Device history record was reviewed and no discrepancies 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 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 NEUTRAL E1 LINER 36MM F
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7785416
• MDR Text Key: 117192478
• Report Number: 0001825034-2018-04754
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000858
• Device Lot Number: 6237888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 54