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

Model Number N/A

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problem Local Reaction (2035)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #11-363662 cocr mod hd std lot #915940, item #11-106052 r/b rloc lhole shl lot #805900, item # 51-104140 tprlc 133 t1 pps lot #3391418.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: 0001825034-2019-02493, 0001825034-2019-02494.

Event Description

It was reported that a patient underwent an initial left hip procedure.Subsequently, approximately four months post op the patient was revised due to metallosis and poly liner fracture.Additional information was requested however, none was 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.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned devices identified that the lock ring was removed and bent.The head showed scuffing, and the liner was fractured.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: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8682334
• MDR Text Key: 147441141
• Report Number: 0001825034-2019-02495
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• PMA/PMN Number: K090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-108223
• Device Lot Number: 841250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 08/28/2019
• 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