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

Model Number N/A

Device Problems Unstable (1667); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2018 - 07751, 0001825034 - 2018 - 07752, 0001825034 - 2018 - 07756.Concomitant products: 51-104150 tprlc 133 t1 pps ho 15x150mm, lot unk; s061140 selex/magnum mod hd 40mm -6 lot unk; 13-104160 m/h 3hole rlc shl nrs 60mm/l25 lot unk; unk part/lot liner.Reported event was confirmed due to review of provided medical records and/or patient x-rays.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.H3 other text : not returned to manufacturer.

Event Description

It was reported the patient was recommended for revision due to impingement, tendonitis, and instability.

• Brand Name: UNKNOWN G7 E1 NEUTRAL LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7768071
• MDR Text Key: 116598018
• Report Number: 0001825034-2018-07759
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 109