MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 40MM +3 HIWALL LNR SZ24; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problems 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 products: 00801804002 62358028 12/14 cocr femoral head 40mm +0, 00771300900 62309332 m/l taper kinectiv stem size 9, 00784803201 62198159 kinectiv modular neck g2, 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: 0002648920 - 2020 - 00025 head, 0001822565 - 2020 - 00152 neck, 0001822565 - 2020 - 00961 stem, 0001825034 - 2020 - 01204 shell.

Event Description

It was reported by patients¿ legal counsel that the patient underwent a right hip revision procedure approximately 5 years post-implantation due to metallosis, tissue damage, periprosthetic fracture and infection, polyethylene failure.All devices removed due to infection.Spacers implanted.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).This follow-up report is being submitted to relay additional information.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.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right hip components explanted at (b)(6).Performed the removal of the entirety of her hip prosthesis with placement of an articulating antibiotic spacer-unknown antibiotic spacer.Treated for severe right hip periprosthetic infection with extensive metallosis due to catastrophic polyethylene failure.Large cavitary defect of the acetabulum as well as fracturing and destruction of the proximal femur including greater trochanter with disruption of the abductor muscles.Treated with iv antibiotics and remained with positive mrsa blood cultures for over 3 weeks.Septic arthritis, severe metallosis; procedure: incision and drainage and debridement right tha with removal of femoral head and acetabular liner and insertion of drains.Presented with pain, xrays reveal erosion of the acetabular liner, ct and mri reveal necrosis of the vasutus lateralis with abundant fluid intra-articular and down the lateral thigh suggestive of infection, esr and crp elevated.Edema in the lateral tissues, black tarry ooze fluid sent for culture suspected as metallosis.Poly was found to be fractured in the acetabulum.Necrosis noted over the vastus lateralis.Femoral head removed but unable to remove femoral stem, so it was left in place as surgeon did not feel the need to extract it at this time as antibiotic spacers and further debridement are planned for the patient.Shell intact and left in place.Drains placed, no other components implanted.Procedure: removal of right hip replacement all components with placement of depuy antibiotic spacer.General, ebl 1000ml.Blood cultures from stage 1 revision returned positive for mrsa bacteria, treated with iv vancomycin, patient concurrently noted to have left shoulder infection/purulence, i&d of left shoulder joint performed.Diffuse metal debris surrounding all tissues, capsule absent, shell and stem well-fixed, proximal bone fragmentation noted with the greater trochanter buried in the soft tissues.Grossly necrotic bone around the femoral components, femoral component removed, anterior femur cracked in the process of removing the implant, remaining distal femur intact, remnant of the lesser trochanter quite thin and encased in soft tissue.No new complaint created as fragmentation of the bone had already been addressed, bone was necrotic and septic, further fragmentation upon implant removal is not an unanticipated event in this case.No additional intervention was required for the complication.Metal stained tissue and scar tissue debrided from the acetabulum, another screw appeared to have largely welded to the acetabular component largely due to what appeared to be the metal femoral head engaging with a metal acetabulum as the poly was largely destroyed¿could not remove the second screw.Upon extraction of the cup, severe cavitary defects noted with mild loss of the posterior wall (pg.5).A portion of the gluteus minimus removed, gluteus medius appeared normal, gluteus maximus intact without issue.All components removed, depuy prostalac spacer placed.Patient received 2 units prbcs due to blood loss.As the reported infection occurred greater than one year from implantation, the patient did not show signs or symptoms of infection within the first year, and the device was sterilized per specification, it is unlikely that the reported infection is related to the implanted zimmer biomet device.The product operated within specification.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 anitbiotic spacers due to infection.No additional information is available.

• Brand Name: E-POLY 40MM +3 HIWALL LNR SZ24
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9859736
• MDR Text Key: 184461320
• Report Number: 0001825034-2020-01203
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• PMA/PMN Number: K090103
• 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: 06/19/2020

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: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: EP-108524
• Device Lot Number: 921590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 62