MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 22X200MM CYL DIST; PROSTHESIS, HIP

Model Number N/A

Device Problems Separation Failure (2547); Material Deformation (2976)

Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.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: 0001825034 - 2022 - 00393.

Event Description

It was reported that during a hip revision due to limb length discrepancy, the surgeon removed the locking screw from the arcos stem components and found the threads of the proximal body to be stripped.The proximal body was unable to be removed from the distal stem.Consequently, the surgeon decided to abort the surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.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: 0001825034 - 2022 - 00393.

Event Description

It was reported that during a hip revision due to limb length discrepancy, the surgeon removed the locking screw from the arcos stem components and found the threads of the proximal body to be stripped.The proximal body was unable to be removed from the distal stem.Consequently, the surgeon decided to abort the surgery.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 reported event was unable to be confirmed due to limited information provided by the customer.A review of the device history records is unable to be conducted as the lot number for the device is unknowns.A definitive root cause cannot be determined.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 additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.

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.1st revision was three years post implantation for mechanical loosening of unknown products with zb components placed.Subsequently, two years from the first revision, a 2nd revision was performed due to limb length discrepancy with custom spacer device.During the procedure noted necrotic synovial tissue, could not decouple the body from the stem due to stripping of the thread, and thin femoral bones.The head and liner were exchanged, and all other implants remained in place.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04): stem.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.During a hip revision, the surgeon removed the locking screw but could not decouple the arcos proximal body (11-301323) from the arcos stem (11-301622) because the threads in the proximal body stripped and the taper disengagement tool could not be/remain assembled to the proximal body.This revision surgery was aimed at implanting a custom arcos adapter and new standard line implants to address the leg length discrepancy of the patient.See attached email conversation.A definitive root cause cannot be determined.The event was confirmed via 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.

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.1st revision was three years post implantation for mechanical loosening of unknown products with zb components placed.Subsequently, two years from the first revision, a 2nd revision was performed due to limb length discrepancy with custom spacer device.During the procedure noted necrotic synovial tissue, could not decouple the body from the stem due to stripping of the thread, and thin femoral bones.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.

• Brand Name: ARCOS 22X200MM CYL DIST
• 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: 13597784
• MDR Text Key: 286108559
• Report Number: 0001825034-2022-00396
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090757
• 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,Followup,Followup,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 11-301622
• Device Lot Number: 224100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White