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 11/29/2017

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.Concomitant products: 51-107120, tprlc 133 mp type1 pps ho 12.0, 3863366; 12-115120, cer bioloxd mod hd 36mm -3 nk, 055620; 110017105, g7 finned 4 hole shell 56f, 3757306; 010000999, g7 screw 6.5mm x 30mm, 3937201.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 07316, 0001825034 - 2018 - 07317, 0001825034 - 2018 - 07318, 0001825034 - 2018 - 07320.

Event Description

It was reported patient underwent total hip arthroplasty and presented at 7.5 months post operatively with worsening pain in the right hip.Workup revealed inflammatory markers.Aspiration revealed periprosthetic joint infection with methicillin-sensitive staphylococcus epidermidis.Patient underwent 2 stage exchange including radical debridement and delayed reimplantation.During the second stage surgery, patient lost 800mls of blood and received 2 units of packed red blood cells.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• 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: 7765166
• MDR Text Key: 116533453
• Report Number: 0001825034-2018-07321
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• 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: 010000858
• Device Lot Number: 3959787
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 111