MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 32MM +3 MAXROM LNR; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 07/08/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: 16-104148 ringloc shell 248490; ep-108222 ringloc liner 269540; 103532 self tapping bone screw 796180; 103532 self tapping bone screw 635030; 103531 self tapping bone screw 921530; 51-109070 taperloc femoral stem 3129447; 650-1056 biolox ceramic head 875010; 650-1064 biolox taper adapter neck 875010.Customer has indicated that the product will not be returned to zimmer biomet for investigation, location of product is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports:0001825034 - 2018 - 07410; 0001825034 - 2018 - 07917; 001825034 - 2018 - 07922 ; 0001825034 - 2018 - 07929; 0001825034 - 2018 - 07940;0001825034 - 2018 - 07948; 0001825034 - 2018 - 07954.

Event Description

It was reported a patient underwent primary left total hip arthroplasty.Patient underwent i&d due to infection and subsequently underwent a two-stage revision approximately 1 month post operatively.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Device history record (dhr) was reviewed with no deviations found.A definitive root cause cannot be determined with the information 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.

Event Description

It was reported a patient underwent primary left total hip arthroplasty.Patient underwent i&d due to infection.Patient underwent a two-stage revision due to infection.Patient reimplanted with permanent devices.

• Brand Name: E-POLY 32MM +3 MAXROM LNR
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7769405
• MDR Text Key: 116639180
• Report Number: 0001825034-2018-07929
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• PMA/PMN Number: PK090103
• 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: 10/25/2018

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: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: EP-108222
• Device Lot Number: 269540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 10/25/2018
• 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: 47 YR
• Patient Weight: 104