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

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: pt-116054-regen/rnglc+ ltd 54mm sz 23-893710, 650-1057-delta ceramic option head dia3 6-811710, 650-1064-cer option type 1 tpr sleve -6 pe 1-938200, 51-106100-tprlc 133 mp type1 pps so 10.0 1-3730440, 103533-ti low profile screw 6.5x30mm ia6.5x30mm-760590, 123741-3/8-24 apical hole plug 1/cup-033860, 103532-bm acet lp dome scw ti s/tap d ia6.5x25mm-893710.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01647.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.

Event Description

It was reported the patient was revised approximately 2 years post implantation due to polyethylene wear.During the procedure it was noted that the polyethylene and locking ring were broken.A new polyethylene and locking ring were implanted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and radiographs by a health care professional.X-rays revealed anterior edge wear on the poly and the retaining ring within the shell had fractured.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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.

Event Description

It was reported the patient was revised approximately 2 years post implantation due to pain and polyethylene wear.During the revision, it was noted that the locking ring was fractured.The liner and locking ring were replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

• 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: 9954169
• MDR Text Key: 187440494
• Report Number: 0001825034-2020-01611
• Device Sequence Number: 1
• Product Code: MAY
• UDI-Device Identifier: 00880304469099
• UDI-Public: (01)00880304469099
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2021
• Device Model Number: N/A
• Device Catalogue Number: EP-108223
• Device Lot Number: 837090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 90