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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2018 - 07710, 0001825034 - 2018 - 07712, 0001825034 - 2018 - 07713.Concomitant medical products: 51-107150 tprlc 133 mp type1 pps ho 15.0 lot 3644040, 12-115120 cer bioloxd mod hd 36mm -3 nk lot 455630, 010000686 g7 bonemaster sld acet shl 58g lot 3744773, 010000859 g7 neutral e1 liner 36mm g lot 3551086.Reported event was confirmed due to review of provided medical records and/or patient x-rays.Dhr was reviewed and no related manufacturing deviations or anomalies were identified.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.Not returned to manufacturer.

Event Description

It was reported the patient had a two-state revision due to infection: (b)(6).No further information available.

Manufacturer Narrative

Udi : (b)(4).Concomitant medical products: 010000666 g7 pps ltd acet shell 58g lot 3744773.

• Brand Name: G7 NEUTRAL E1 LINER 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7767774
• MDR Text Key: 116568830
• Report Number: 0001825034-2018-07714
• 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,study
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000859
• Device Lot Number: 3551086
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 09/20/2018
• Supplement Dates FDA Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 86