MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS BRCH SZ A HI 60MM; PROTHESIS, HIPS

Model Number N/A

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 11-301414 arcos 14x115mm cyl dis 691570.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00656.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.

Event Description

It was reported that a patient had a left total hip arthroplasty with uncemented competitor implants on an unknown date.In an unknown timeframe postop, the patient fell and experienced a periprosthetic fracture with loosening of the femoral component.The patient underwent revision of the femoral components with implantation of zb components and retention of the initial cup and liner.The fracture was stabilized with fiber tape and cerclage wires, and the procedure was completed without complications.Subsequently, the patient returned for a second revision two years post implantation due to loosening and subsidence of the femoral stem.During the revision, the stem and head were replaced, and the initial cup and liner were retained.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records were not provided for this revision; however, the per was reviewed by a health care professional.Review of the available records identified the following: the patient had a left tha with uncemented competitor implants on an unknown date.The patient underwent a revision due to periprosthetic fracture and loosening, zb product was placed with competitor product.Another revision was performed for loosening and stem subsidence.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total hip arthroplasty with likely loosening of the femoral stem and possible osteolysis of the greater trochanter as well as subsidence.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.A definitive root cause cannot be identified.This complaint cannot be confirmed, as the mmi report does not definitively confirm loosening or subsidence.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.

• Brand Name: ARCOS BRCH SZ A HI 60MM
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18847364
• MDR Text Key: 337017823
• Report Number: 0001825034-2024-00657
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 0880304473768
• UDI-Public: (01)0880304473768(17)280822(10)174250
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 11-301111
• Device Lot Number: 174250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2018
• 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: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female