MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY 32MM RLC LNR; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001825034-2021-02115.

Event Description

It was reported during surgery the liner did not fit the cup.A new liner wasn¿t available.A new cemented cup was implanted after removal of the uncemented cup.15 min delay.No additional information.

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 following sections were updated/corrected; updated: b4, b5, d4, d9, g3, h2, h3, h6.Complaint sample was evaluated and the reported event was confirmed.One m/h sld/apx hle rnglc shl 54mm and one epoly 32mm rlc lnr mrom sz24 were returned and evaluated.Upon visual inspection the liner has indentations on near the locking feature around the device.The shell has had the locking ring bent and twisted out of the ring guide.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

• Brand Name: EPOLY 32MM RLC LNR
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12189255
• MDR Text Key: 262241379
• Report Number: 0001825034-2021-02116
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K100048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2022
• Device Model Number: N/A
• Device Catalogue Number: EP-105934
• Device Lot Number: 490490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#11-104054 RNGLC SHL 54MM LOT#6092384; CAT#11-104054 RNGLC SHL 54MM LOT#6092384