MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 36MM +3 HIWALL LNR SZ23; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date unknown.Implanted in (b)(6) 2014.Concomitant medical products: 650-1057 ¿ biolox delta head ¿ 174850, 650-1064 ¿ ceramic taper sleeve ¿ 195410, 13-104150 ¿ mallory head shell ¿ 750520, unknown stem ¿ unknown part and lot, therapy date: unknown.Report source: (b)(6).Customer has indicated that the product will not be returned for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a revision surgery at an unknown amount of time post implantation due to the liner component breaking.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.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.

Event Description

No additional event information to report at this time.

• Brand Name: E-POLY 36MM +3 HIWALL LNR SZ23
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8906902
• MDR Text Key: 154753186
• Report Number: 0001825034-2019-03669
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• PMA/PMN Number: K090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2019
• Device Model Number: N/A
• Device Catalogue Number: EP-108323
• Device Lot Number: 306240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2019
• 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