MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET E1 POLY LINER; HIP PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Joint Dislocation (2374); Numbness (2415); Ambulation Difficulties (2544)

Event Date 02/13/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for evaluation, due to the implant remains implanted.The evaluation is in process.Once the evaluation has been completed, a follow-up mdr will be submitted.Maude report mw5073429.Product remains implanted.16-104150 ringloc+ shell lot # 847500.Multiple mdr reports were filed for this event.Please see associated reports: 0001825034-2018-00376, 00377.Remains implanted.

Event Description

It was reported a patient is experiencing worsening pain, a limp, ambulation difficulties, muscle spasms, muscle damage, and numbness from hip down to toes for the past 2 years.Patient also alleges that the hip "tried to dislocate" on two occasions.Patient reports being prescribed percocet for pain.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01649-1, 0001825034-2018-00377-2, 0001825034-2018-00376-2.

Event Description

It was reported that a patient started experiencing pain 4 years post implantation.The patient is experiencing worsening pain, a limp, ambulation difficulties, muscle spasms, muscle damage, and numbness from hip down to toes for the past 2 years.Patient also alleges that the hip "tried to dislocate" on two occasions.Patient reports being prescribed percocet for pain.

Manufacturer Narrative

Concomitant medical products: item# 11-363662, femoral head, lot# 047130.Item# 14-103201, taperloc stem, lot # 606010.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.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.Multiple reports were filed for this event, please see associated reports: 0001825034-2018-00376-1, 0001825034-2018-00377-1, 00018.

Event Description

It was reported that a patient started experiencing pain 4 years post implantation.

• Brand Name: BIOMET E1 POLY LINER
• Type of Device: HIP PROSTHESIS
• 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: 7249206
• MDR Text Key: 99297268
• Report Number: 0001825034-2018-00377
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2015
• Device Model Number: N/A
• Device Catalogue Number: EP-108323
• Device Lot Number: 301360
• Other Device ID Number: (01) 00880304469006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other