MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X190MM SPL TPR DIST; PROTHESIS, HIP

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Unequal Limb Length (4534)

Event Date 08/19/2023

Event Type  Injury  

Event Description

It was reported that approximately 7 years post implantation the patient had gluteal issues and a malrotated arcos stem, with a leg length discrepancy.The length of the discrepancy was unspecified.The surgical technique was followed, and there were no signs of loosening or subsidence.The old stem was removed, and a new arcos stem was inserted.There was no surgical delay and no contributing conditions related to the event.Though requested, no additional information was received.

Manufacturer Narrative

(b)(4).D6a: implant date: the device was implanted sometime in 2016.G2: foreign: country: australia.Multiple mdr reports were filed for this event, please see associated report: 0001825034 -2023 -02037.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

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: b4; b5; g3; h2; h3; h4; h6.Proposed component code: mechanical (g04) ¿ stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint could not be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause could not 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.

• Brand Name: ARCOS 15X190MM SPL TPR DIST
• 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: 17698670
• MDR Text Key: 322833968
• Report Number: 0001825034-2023-02036
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304480513
• UDI-Public: (01)00880304480513(17)270221(10)812900
• 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: 01/03/2024

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: 11-300915
• Device Lot Number: 812900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female