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

Catalog Number EP-108323

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01418.Report source: canada.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported a patient underwent a revision procedure for unknown reasons.The cup and liner were removed and replaced.Attempts have been made and no further information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.An e-poly 36mm +3 hiwall lnr sz23, part#: ep-108323 from lot: 272260, was returned and evaluated against the complaint.No markings were observed on the returned liner.The liner was returned in 3 pieces.The pieces of deformed and covered in a dark debris.Dhr was reviewed and no discrepancies related to the reported event were found.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; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17209211
• MDR Text Key: 317937398
• Report Number: 0001825034-2023-01417
• Device Sequence Number: 1
• Product Code: MAY
• UDI-Device Identifier: 00880304469006
• UDI-Public: (01)00880304469006(17)211124(10)272260
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2021
• Device Catalogue Number: EP-108323
• Device Lot Number: 272260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2016
• 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
• Treatment: UNK CUP.
• Patient Outcome(s): Required Intervention; Hospitalization