MAUDE Adverse Event Report: ZIMMER TMT ELLIP/CUP HEC W/ALO-INSERT DIA28/52 0DEG; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation Difficulties (2544); Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: switzerland.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient was found to have a ceramic fracture, atraumatic discovered during an office visit.The revision surgery to new implants was performed 2 weeks after diagnosis.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  no product was returned; dimensional evaluations could not be performed.Photographs provided show the explanted and fractured ceramic.Lot identification is necessary for review of device history records.Lot identification was not provided.Insufficient information provided.Unable to perform a compatibility check.Review of complaint history found no additional related issues for this item, however, as the lot number is unknown, an additional review could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient presented with atraumatic hip and groin pain with restriction of movement.Entering on crutches, limping/antalgic gait, no swelling, tenderness, or redness.X-rays show fractured ceramic parts without signs of loosening or periprosthetic fracture.Patient underwent revision surgery with findings of: bursitis with torn gluteus minimus tendon noted.Significant capsular fibrosis (scar tissue).Removal of ceramic shards and synovectomy performed.Postop x-ray shows removal of all fragments.Initial stem left intact, all other components replaced with competitor product.No additional information available after competitor product implanted.Radiograph/images were provided but not sent to mmi for review as medical records provide information needed and image review will not enhance the investigation.The complaint is confirmed through images and medical records.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 further event information available at the time of this report.

Event Description

It was reported that a patient had bilateral total hip arthroplasties and underwent right hip revision on 22 years post implantation due to pain and difficulty ambulating.X-rays showed ceramic implant fracture.During the revision, bursitis, capsular fibrosis, and a tear of the gluteus minimus tendon were debrided and repaired.The surgeon noted that the ceramic insert in the polyethylene was completely broken, but the ceramic head was intact.A compatible head and liners were no longer available, so the cup was exchanged as well.The initial stem remained intact with all other implants being replaced with competitor product.Post-op x-ray confirmed all ceramic fragments had been removed.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Additional associated products unk ceramic head 28l lot# unk.Unk sl stem lot# unk.

• Brand Name: ELLIP/CUP HEC W/ALO-INSERT DIA28/52 0DEG
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18817469
• MDR Text Key: 336673246
• Report Number: 3005751028-2024-00002
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K001759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02-272-28521
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/25/2024; 04/30/2024
• Supplement Dates FDA Received: 04/24/2024; 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male