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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL LONGEVITY; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

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ZIMMER BIOMET, INC. TRABECULAR METAL LONGEVITY; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Back to Search Results
Catalog Number 00711506236
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 05/19/2026
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event or Problem Description
It was reported that approximately two months post-implantation, the patient underwent a hip revision due to dislocation.Attempts have been made and no further information has been provided.
 
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Brand Name
TRABECULAR METAL LONGEVITY
Common Device Name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key25473339
Report Number0001822565-2026-01877
Device Sequence Number10426522
Product Code KWZ
UDI-Device Identifier00889024670150
UDI-Public(01)00889024670150(17)290924(10)66674843
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K072121
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2026
Device Explanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Health Professional,Company Representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 08/12/2026
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 Lay User/Patient
Device Catalogue Number00711506236
Device Lot Number66674843
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/19/2026
Supplement Date Received by Manufacturer08/07/2026
Initial Report FDA Received Date06/11/2026
Supplement Report FDA Received Date08/12/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured09/25/2024
Is the Device Labeled for Single Use? (Y/N) Yes
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention; Hospitalization;
Patient Age79 YR
Patient SexFemale
Patient Weight154 LB
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