MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 40MM +3 HIWALL LNR SZ24; PROTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651); Tissue Breakdown (2681)

Event Date 12/14/2012

Event Type  Injury  

Event Description

It was reported the patient underwent an initial left total hip arthroplasty.Four years post implantation the patient was revised due to dislocation.It was noted during the revision the patient had instability posteriorly, tissue damage to the posterior capsule, and bone loss.The shell, liner, and head were exchanged without complications.The stem remained implanted.

Manufacturer Narrative

(b)(4).D10: s001140 selex/magnum mod hd 40mm std 922250.11-106054 r/b rloc lhole shl 54mm sz 24 mm lnr sz 980550.103533 ti low profile screw 6.5x30mm 644200.X180312 bi-metric/x por nc 12x140 336810.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01024.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on review of medical records.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: irreducible dislocation, posterior superior dislocation with part of capsule in cup preventing relocation.Noted instability posteriorly though was tight.Forward flexion could not be achieved due to some loss of bone preventing ideal position.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: E-POLY 40MM +3 HIWALL LNR SZ24
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16918285
• MDR Text Key: 315071892
• Report Number: 0001825034-2023-01023
• Device Sequence Number: 1
• Product Code: MAY
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2012
• Device Model Number: N/A
• Device Catalogue Number: EP-108524
• Device Lot Number: 695170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female