MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOMXL 36MM RLC LNR MROM SZ25; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Difficult to Insert (1316); Difficult To Position (1467); Fitting Problem (2183); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 12/05/2014

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Complaint sample was evaluated and the reported event was confirmed.Product evaluation stated, "the fractured rim of the liner was worn to the point where the machine lines were removed.This suggests that the modular head was loading against the unsupported polyethylene above the rim.90 degrees from the fracture surface, there is plastic deformation of the rim that is consistent with impingement of the stem on the polyethylene liner.This, coupled with the proposed position of the modular head, suggests that the shell and liner may have been placed vertically and with a significant amount of version." dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Investigation results concluded that the reported event may have been due to the shell and liner being placed vertically and with a significant amount of version.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.This report is being submitted late as it has been identified in remediation.

Event Description

Revision due to fracture of liner and dislocations.Additional information received from operative report noted patient was revised due to pain and a fractured liner.Operative report further noted the locking ring would not engage into the acetabular cup during the revision procedure.

• Brand Name: ARCOMXL 36MM RLC LNR MROM SZ25
• Type of Device: PROSTHESIS, HIP
• 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: 6946062
• MDR Text Key: 89261013
• Report Number: 0001825034-2017-08437
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: XL-105995
• Device Lot Number: 893680
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR