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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2022

Event Type  Injury  

Event Description

It was reported patient underwent a right hip revision due to implant fracture.The lip of the liner cracked and had to be removed.Locking mechanism was damaged so entire cup was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Patient in her 50s.Concomitant products: 650-1057- cer bioloxd option hd 36mm- 2964345; 650-1064- cer option type 1 tpr sleve -6- 2962119; 13-104052- m/h radial solid/apx shl 52mm- 604150.Customer has indicated that the product will not be returned to zimmer biomet for investigation, requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Requested but not returned by hospital.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6.Reported event was unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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.

Event Description

No additional information on the reported event.

• 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
• 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: 13385412
• MDR Text Key: 284628289
• Report Number: 0001825034-2022-00185
• Device Sequence Number: 1
• Product Code: MAY
• UDI-Device Identifier: 00880304469099
• UDI-Public: (01)00880304469099(17)241104(10)639280
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: EP-108223
• Device Lot Number: 639280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female