MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A STD 80MM; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	08/19/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).D6a: implant date: the device was implanted sometime (b)(6) 2016.G2: foreign: country: australia.Multiple mdr reports were filed for this event, please see associated report: 0001825034 -2023 -02036.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 or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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 CON SZ A STD 80MM
• Common Device Name: 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: 17698674
• Report Number: 0001825034-2023-02037
• Device Sequence Number: 6719225
• Product Code: KWA
• UDI-Device Identifier: 00880304474659
• UDI-Public: (01)00880304474659(17)270530(10)470890
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301341
• Device Lot Number: 470890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female