MAUDE Adverse Event Report: ZIMMER BIOMET, INC. IMPACT POROUS ACET SHELL 54MM; PROSTHETIC, HIP

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems Cyst(s) (1800); Pain (1994)

Event Date 08/20/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item # 163132 item name 28mm mod hd ceramic std nk lot #163132, item # 103531 item name ti low profile screw 6.5x20mm lot #083740, item # 103530 item name ti low profile screw 6.5x15mm lot #442770.The device will not be returned for analysis as product location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04446.

Event Description

It was reported the patient underwent a right revision procedure approximately 13 years post implantation due to wear, likely secondary to vertical position of the cup.The patient had a recent accident at work and went to see his physician with mild buttock and thigh pain.It was also noted the patient had an osteolytic cyst during the procedure which was removed.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent a right tha on an unknown date approximately 13 years prior.(b)(6)2009 office visit pt complaint of some mild buttock and thigh pain.X-ray findings show evidence of asymmetric poly wear without osteolysis.Operative report demonstrated excellent in-growth, removed head without difficulty, morse taper appeared to be in excellent condition.Moderate amount of bursitis about trochanteric claw.Cables cut and removed claw without difficulty.Large posterior osteolytic cyst approximately 3 to 4 cm in length and 2 cm in width, removed.Packed with autologous remings and allogenic crushed cancellous bone graft.Locking mechanism damaged by wear which was worn through a bit of poly onto the metallic shell.Cup was a bit too vertical, possibly resulting in the superior wear pattern.Decided based on vertical position of cup, difficulty with locking mechanism, and unavailability of cup presently to revise entire acetabular component.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.

• Brand Name: IMPACT POROUS ACET SHELL 54MM
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11109262
• MDR Text Key: 224812257
• Report Number: 0001825034-2020-04445
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2003
• Device Model Number: N/A
• Device Catalogue Number: 112054
• Device Lot Number: 861440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention