MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 62 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Positioning Failure (1158); Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583)

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

Event Date 02/02/2011

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00630506236- liner standard 3.5 mm offset 36 mm i.D.For use with 62 mm o.D.Shell- 61436931.00771100900- femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 9 standard offset- 61652411.00801803602- femoral head sterile product do not resterilize 12/14 taper- 61687775.00625006530- bone scr 6.5x30 self-tap- 61504843.006250065200- bone screw self-tapping 6.5 mm dia.20 mm length- 60892261.00620006222 lot 61483204 trilogy shell: inadequate purchase not used.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product was implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device was implanted.

Event Description

It was reported during an initial left total hip arthroplasty that the surgeon had extensive difficulty getting the trilogy shell to seat due to inadequate purchase.The surgeon decided to place a trabecular metal shell instead which seated better.This was screwed into the acetabulum although the surgeon noted the anteversion was questionable.While trialing the remaining components, the hip dislocated and was unstable.It was determined the shell was placed with too much anteversion.The shell was removed, position corrected, and the same shell and screws were secured back into the bone.The remaining components were placed without further complication.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.The following sections were updated/corrected updated: d4; g3; h2; h3; h4; h6 reported event was confirmed via medical records reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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: SHELL POROUS WITH CLUSTER HOLES 62 MM O.D.
• 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: 12671361
• MDR Text Key: 277636345
• Report Number: 0001822565-2021-03025
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 00620006222
• Device Lot Number: 61483204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2004
• 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
• Treatment: SEE H10
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White