MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP MOLD STEM W/REINF 11X135; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Non-union Bone Fracture (2369)

Event Date 04/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: (b)(6) 2019.Concomitant products: unknown cup, unknown liner, unknown head.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device 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 patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately one month post implantation due to femoral stem fracture and periprosthetic fracture.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported patient underwent initial hip arthroplasty with unknown product which was complicated with dislocations and recurrent infections resulting in revision with unknown products.The patient underwent removal of the unknown tha approximately 15 years post implantation with placement of a zb cement spacer, cemented acetabular liner, and cable stabilization for the required trochanteric osteotomy.Immediate and postop day 1 x-rays showed no complications.Longer x-rays of the femur taken postop day 2 were suspicious for a nondisplaced incomplete fracture of the femoral shaft 3.3cm distal to the spacer stem.Approximately one month post revision, the patient was climbing at ladder on his work boat and fractured the stem of the spacer just above its insertion point in his right femur which also fractured the adjacent femoral bone.An open reduction internal fixation was performed with no indication of revision of product.The patient continued follow up with infectious disease specialists for antibiotic management due to slow healing of the femur after the orif.Approximately two years post revision, he felt a pop in the hip and was found to have fracture of the antibiotic spacer at the mid-distal spacer and in the proximal femur between the orif.Revision surgery has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a2; a3; a4; a5; b5; b7; d1; d2; d4;d6; d10; g4; h6 d10: ref (b)(4)lot unk; g7 acetabular liner 36mm e ref 650-1058 lot unk; 40mm biolox delta ceramic femoral head ref(b)(4) lot unk; +6mm biolox delta type 1 taper adapter ref 110034355 lot unk; biomet bone cement r 1x40.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

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.Reported event was confirmed by review of medical records received.Review of the available records identified the patient underwent initial hip arthroplasty with unknown products and was later revised due to complications.The patient was then replaced with spacer and zimmer biomet implants.X-ray taken pod 2 shows transverse lucency in the mid 1/3 of the right femur, suspicious for a nondisplaced incomplete fracture of the femoral shaft, located approximately 3.3cm beyond the femoral stem portion.It was later reported that the patient was climbing a ship¿s ladder aboard a tow boat, and the zimmer biomet hip replacement hardware fractured just above its insertion point in his right femur.Patient felt a pop in the hip and was found to have fracture of the antibiotic spacer.There is a loss of proximal femoral bone and a section of this appears non-viable.Right hip spacer with fracture of the mid-distal spacer and proximal femur in between the femoral shaft plate and the scarab plate on the gt.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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 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 updated: b3; b5, d6; h6.

Event Description

It was reported patient underwent an initial right total hip arthroplasty with unknown product which was complicated with dislocations and recurrent infections resulting in revision with unknown products.The patient underwent removal of the unknown tha approximately 15 years post implantation with placement of a zb cement spacer, cemented acetabular liner, and cable stabilization for the required trochanteric osteotomy.Immediate and postop day 1 x-rays showed no complications.Longer x-rays of the femur taken postop day 2 was suspicious for a nondisplaced incomplete fracture of the femoral shaft 3.3cm distal to the spacer stem.No additional intervention was provided, and the patient was discharged after an uncomplicated hospital stay.According to legal documents, the patient was climbing at ladder on his work boat and fractured the stem of the spacer just above its insertion point in his right femur which also fractured the adjacent femoral bone.An orif was performed with no indication of revision of product at this point.The patient continued follow up with infectious disease specialists for antibiotic management due to slow healing of the femur after the orif.The patient felt a pop in the hip and was found to have fracture of the antibiotic spacer at the mid-distal spacer and in the proximal femur between the orif plates.It was reported that the patient underwent a right total hip revision without complications.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Mechanical (g04) - stem.Reported event was confirmed by review of medical records received.Review of the available records identified the patient underwent initial hip arthroplasty with unknown products and was later revised due to complications.The patient was then replaced with spacer and zimmer biomet implants.X-ray taken pod 2 shows transverse lucency in the mid 1/3 of the right femur, suspicious for a nondisplaced incomplete fracture of the femoral shaft, located approximately 3.3cm beyond the femoral stem portion.It was later reported that the patient was climbing a ship¿s ladder aboard a tow boat, and the zimmer biomet hip replacement hardware fractured just above its insertion point in his right femur.Patient felt a pop in the hip and was found to have fracture of the antibiotic spacer.There is a loss of proximal femoral bone and a section of this appears non-viable.Right hip spacer with fracture of the mid-distal spacer and proximal femur in between the femoral shaft plate and the scarab plate on the gt.The patient underwent revision right total hip arthroplasty to remove spacer components.The patient reports no pain and improved mobility with activities.Less tightness and discomfort in right hip and quad; complaint of right hip discomfort secondary to right femur fracture; secondary to infection, muscle weakness (generalized), unspecified abnormalities of gait and mobility.Review of the device history records identified no deviations or anomalies during manufacturing it was reported the spacer fracture while the patient was climbing a ship¿s ladder aboard a tow boat.However, a definitive root cause could not be determined with the information provided.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 further event information available at the time of this report.

• Brand Name: HIP MOLD STEM W/REINF 11X135
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12336362
• MDR Text Key: 267115914
• Report Number: 0001825034-2021-02424
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• 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: 431191
• Device Lot Number: 877440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2019
• 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 Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White