MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HOODED ENHANCED ACETABULAR INSERT SIZE 32 MM I.D./65 MM O.D.; PROTHESIS, HIPS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Necrosis (1971); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Unequal Limb Length (4534); Swelling/ Edema (4577)

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 12-115117 cer bioloxd mod hd 32mm +6 nk 673000.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

It was reported by legal initial left total hip arthroplasty on an unknown date with unknown components.An orif was performed for a distal femoral fracture.The first revision occurred due to mechanical loosening of unknown products with zb components placed.Subsequently, the patient had a second revision due to limb length discrepancy with custom spacer device.During the procedure, necrotic synovial tissue, could not decouple the body from the stem due to stripping of the thread, and thin femoral bones was noted.The head and liner were exchanged, and all other implants remained in place.The patient has reported ongoing and chronic pain, swelling, and continued leg length discrepancy since the revision.The patient is now pending another custom implant due to the inability to remove the previous stem.

Manufacturer Narrative

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.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.A review of the available records identified the patient to have lld, pain, swelling, and possible dislocation, and during the revision the stem/cone body were difficult to remove.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total hip arthroplasty with significant bone loss along the femoral stem and possible evidence of osteolysis along the greater trochanter.A definitive root cause cannot be determined.This complaint was confirmed based on the provided medical records.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.

Event Description

No additional event information to report at this time.

• Brand Name: HOODED ENHANCED ACETABULAR INSERT SIZE 32 MM I.D./65 MM O.D.
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18276016
• MDR Text Key: 329848437
• Report Number: 0001822565-2023-03499
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 433832065
• Device Lot Number: 62365008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2013
• 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: Male
• Patient Weight: 75 KG
• Patient Race: White