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

Model Number N/A

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The 11-104052 ¿ mallory/head actabular shell ¿ 418660.105423 ¿ acetabular lock ring - 332340.Therapy date: (b)(6) 2015.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the product is unknown.The investigation is in process.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 -018 -06455.0001825034 -2018 -06467.

Event Description

It was reported patient underwent left hip revision approximately 6 years post implantation due to pain.It was found that the liner was damaged causing disassociation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed by review of medical records.Review of op notes confirm that patient was seen for increasing pain, and decreasing function.Catastrophic failure noted on x-ray.Femoral head appeared eccentric and signs of failure in the locking ring apparent.During the revision, the head was severely burnished and was removed.The stem was well-fixed, it was removed; a new cup was implanted with appropriate anteversion abduction angle.No further complications noted.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: E-POLY 36MM +3 MAXROM LNR SZ23
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7758414
• MDR Text Key: 116294792
• Report Number: 0001825034-2018-06461
• 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: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: EP-108223
• Device Lot Number: 205980
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2018
• 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: 58 YR
• Patient Weight: 72