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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. ARCOS 15X190MM SPL TPR DIST; PROTHESIS, HIP Back to Search Results
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.
 
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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 Key17698670
MDR Text Key322833968
Report Number0001825034-2023-02036
Device Sequence Number1
Product Code KWA
UDI-Device Identifier00880304480513
UDI-Public(01)00880304480513(17)270221(10)812900
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K090757
Number of Events Reported1
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 NumberN/A
Device Catalogue Number11-300915
Device Lot Number812900
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 Received09/07/2023
Supplement Dates Manufacturer Received12/22/2023
Supplement Dates FDA Received01/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexFemale
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