MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Congenital Defect/Deformity (1782); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 03343, 0001822565 - 2022 - 03344, 0001822565 - 2022 - 03345.

Event Description

According to legal allegations, an initial left total hip was performed due to congenital hip dysplasia.Subsequently the patient felt a bump which progressed to increased pain and difficulty walking.The patient underwent a debridement with irrigation and pathology confirmed a neutrophilic abscess with metallosis.Later, the patient underwent the first part of a two-stage revision due to an unknown infection, metallosis, elevated metal ions, and a pseudotumor.During the stage i revision, the head was unable to be removed from the taper, extensive debridement of friable soft tissue and surrounding metallosis was performed, loss of bone around calcar and greater trochanter region, and the acetabulum was found deficient secondary to the patient¿s congenital hip dysplasia.All components, except the stem were removed and an antibiotic spacer was placed.The patient underwent stage ii of the revision.During the surgery the abductor muscles were found to be destroyed, significant scar tissue was found throughout, the acetabulum had to be recreated, and significant bone loss was found.The loose femoral stem was removed and noted to have complete destruction of the proximal femur and proximal trochanter.The surgery was completed without further complications and competitor product was implanted.Attempts have been made and no further information has been provided at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: mechanical (g04) - stem.Reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues, unable to bear weight, increase in pain, definite infection, cobalt and chromium levels noted, great concern with loss of soft tissue, infected left hip with pseudotumor.Visual examination of the provided pictures identified the head/stem/shell all explanted but no other information can be obtained from the image.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided, and a corrected report will be filed under mfr number: (b)(4).

Event Description

No further information at the time of this report.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• 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: 15886697
• MDR Text Key: 304539942
• Report Number: 0001822565-2022-03342
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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,Followup
• Report Date: 02/28/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 02/01/2023; 02/06/2023
• Supplement Dates FDA Received: 02/03/2023; 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNK CUP LOT935736.; UNK HEAD.; UNK TAPER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female