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

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

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

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# unknown, unknown head, lot# unknown; item# unknown, unknown cup, lot# unknown.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent revision of total hip arthroplasty approximately 6 months after initial implantation due to dislocation, fractured liner, and pain.Attempts have been made to obtain additional information; however, none is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: item# unknown, unknown stem, lot# unknown.Complaint sample was evaluated and the reported event was confirmed via operative notes and visual inspection.Op notes indicated patient was dislocated with slight vertical position of cup.The acetabular cup was checked and noted the liner had cracked in one place, and there was a small free piece of the liner that was removed.The rest of the liner was removed using osteotome in multiple technique.Upon visual inspection the liner had fractured.A small amount of debris imbedded in the outer sphere of the liner.A dimensional analysis cannot be performed due to its resulting damage.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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: 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: 7911779
• MDR Text Key: 121845640
• Report Number: 0001825034-2018-09077
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2021
• Device Model Number: N/A
• Device Catalogue Number: EP-108323
• Device Lot Number: 272260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2018
• 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: 86 YR
• Patient Weight: 83