MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET HIP SYSTEM 36MM COCR MOD HD -3MM; PROSTHESIS, HIP

Catalog Number	11-363661
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 30113607, lot# 66736316, 36mm i.D.Size g 10a liner.G2: foreign: chile.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that an initial left total hip arthroplasty was performed.Subsequently, the patient was revised approximately 3 years later due to pain and difficulty ambulating from poly liner wear and dislocation.The head and liner were replaced while the stem and cup remain intact.It was reported that no further information is available.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; d9; g3; h2; h3; h4; h6.Proposed component code: mechanical (g04)- head.Visual examination of the returned product identified outer spherical surface shows wear damage on one side with dark scrapes and scratches.Flat surface shows indentations.Taper hole has dark foreign discoloration.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed.There was an intra-acetabular displacement of the femoral head, suggesting wear.It was noted the positioning was eccentric.A revision occurred with an x-ray showing adequate congruence of the components.X-ray images not sent to mmi as radiology reports were also provided.A definitive root cause cannot be determined.This complaint was confirmed based on the provided medical records.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 or Problem Description
No further information at the time of this report.

• Brand Name: BIOMET HIP SYSTEM 36MM COCR MOD HD -3MM
• Common Device Name: PROSTHESIS, 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: 21255775
• Report Number: 0001825034-2025-00212
• Device Sequence Number: 15722604
• Product Code: JDI
• UDI-Device Identifier: 00887868307942
• UDI-Public: (01)00887868307942(17)311027(10)J7133171
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K032396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 06/18/2025

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 Number: 11-363661
• Device Lot Number: J7133171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 02/10/2025; 06/17/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/12/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male