MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ B HI 70MM; PROTHESIS, HIP

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Unspecified Infection (1930)

Event Date 12/20/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: foreign: australia.D10: cat# 11-300915 lot# 977420 arcos st dist stem ti 15x190 bi, cat# 11-363663 lot# 553440 36mm cocr mod hd +3mm , cat# unk lot# unk unknown cup , cat# unk lot# unk unknown liner, cat# 00223200418 lot# unk cable ready gtr cocr cable, cat# 00223200418 lot# 65228591 cable ready gtr cocr cable, cat# 00223200418 lot# 65232761 cable ready gtr cocr cable, cat# 00223200418 lot# 65232765 cable ready gtr cocr cable, cat# 00223200418 lot# 65240290 cable ready gtr cocr cable, cat# 00236901435 lot# unk 3.5mmx14mm ti locking screw, cat# 00236903835 lot# unk 3.5mmx14mm ti locking screw, cat# 00236904435 lot# unk 3.5mmx14mm ti locking screw, cat# 47-9986-021-26 lot# 56715038 long ost blade 10mmx5, cat# 00236901635 lot# unk 5mmx16mm ti locking screw, cat# 00236902235 lot# unk 5mmx16mm ti locking screw cat# 00236903035 lot# unk 5mmx16mm ti locking screw, cat# 02.02150.300 lot# 3034939 ncb clamp-screw, cat# 02.02150.300 lot# 3059655 ncb clamp-screw, cat# 02.02150.300 lot# unk ncb clamp-screw, cat# 02.02263.000 lot# 2934192 ncb pp pf plate, short, right, l115, cat# 02.02263.201 lot# 3028988 ncb pp troc plate, right, narrow g , cat# 02.03150.042 lot# unk ncb screw 5.0 l=42, cat# 02.03151.016 lot# unk ncb unicortical scr 5.0 l=16m, cat# 02.03151.018 lot# unk ncb unicortical scr 5.0 l=18m, cat# 02.03151.020 lot# unk ncb unicortical scr 5.0 l=20m, cat# 290.20.280 lot# unk kirschner wire l280.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00400, 0001825034-2024-00401, 0001825034-2024-00403, 0001825034-2024-00436.

Event Description

It was reported that approximately 21 months post implantation of a right total hip arthroplasty, the patient was revised due to the cup migrating medially, a loose stem, and an infection.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6 h6: component code: mechanical (g04) - stem no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: sizing of the implant was appropriate.Acetabuli protrusio of the cup.Possible superior migration of a lateral femoral plate and screw fixation device now perched along the anterior superior iliac spine.A review of the device history records identified no deviations or anomalies during manufacturing.Insufficient information provided, as part and lot identification are necessary for compatibility checks, and neither were provided for the liner and shell components.During the investigation process, the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.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 further event information is available at the time of this report.

• Brand Name: ARCOS CON SZ B HI 70MM
• Type of Device: PROTHESIS, HIP
• 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: 18730941
• MDR Text Key: 335723900
• Report Number: 0001825034-2024-00399
• Device Sequence Number: 1
• Product Code: KWA
• 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: 02/21/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301332
• Device Lot Number: 556460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• 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): Required Intervention; Hospitalization
• Patient Sex: Male