MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FEMORAL STEM SIZE 9; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Sepsis (2067); Swelling (2091); Hypovolemia (2243); Blood Loss (2597)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product(s): 00801804002 62358028 12/14 cocr femoral head 40mm +0; 00784803201 62198159 kinectiv modular neck g2; ep-108524 921590 e-poly 40mm +3 hiwall lnr sz24; 103531 939930 ti low profile screw 6.5x20mm; 106054 884870 ran/bur rnglc shl 54mm sz 24; 103531 405190 ti low profile screw 6.5x20mm.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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 - 2020 - 00152 neck, 0002648920 - 2020 - 00025 head, 0001825034 - 2020 - 01203 liner, 0001825034 - 2020 - 01204 shell.

Event Description

It was reported that the patient underwent a right hip revision procedure approximately 5 years post-implantation due metallosis, tissue damage, periprosthetic fracture and infection, polyethylene failure.Attempts were made to obtain additional information; however, none was available.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Operative notes were provided for the two stage revision surgery.The patient underwent a revision procedure due to metallosis, tissue damage, periprosthetic fracture and fracture, and polyethylene failure.Patient was presented with pain, xray confirmed erosion of the acetabular liner, ct and mri confirmed necrosis of the vasutus lateralis with abundant fluid intra-articular and down the lateral thigh suggesting infection, esr and crp.Edema was noted in the lateral tissues; black tarry ooze fluid was sent for culture suspected as metallosis.Drainage and debridement was performed of the right tha with removal of the femoral head and fractured liner.Necrosis was noted over the vastus lateralis.Stem was left in place as antibiotic spacers and further debridement are planned for the patient.Shell was left intact.Drains were placed.The patient underwent the second stage revision.Blood cultures returned positive for mrsa bacteria, patient had concurrent left shoulder infection/purulence.Stem and shell found well fixed, proximal bone fragmentation noted with the greater trochanter buried in the soft tissue.Grossly necrotic bone noted around femoral components and anterior femur cracked in the process of removing the stem.Metal stained tissue and scar tissue debrided from acetabulum.Screw appeared to have welded to acetabular component due to the femoral head engaging with the metal acetabulum from the liner fracturing.Upon cup extraction, severe cavitay defects noted with mild loss of the posterior wall.All components removed, spacer placed.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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

It was reported that the patient underwent a right hip revision procedure approximately 5 years post-implantation due to metallosis, tissue damage, periprosthetic fracture, infection, polyethylene failure and a large cavitary defect of the acetabulum.Two-part surgery to remove all devices and replace with antibiotic spacers due to infection.No additional information is available.

• Brand Name: MODULAR FEMORAL STEM SIZE 9
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9860329
• MDR Text Key: 191863925
• Report Number: 0001822565-2020-00961
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 00771300900
• Device Lot Number: 62309332
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 62