MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZB 12/14 COCR HD 36MM X +3.5; PROSTHESIS, HIP

Catalog Number	802203603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00623; 0001822565-2024-00625; 0001825034-2024-00483.D10: cat #: 30123605 / g7 vit e high wall lnr 36mm e / lot #: 65312753.Cat #: 574103050 / avenir cmpl ha var nc size 5 / lot #: 3064721.Cat #: 010000663 / g7 pps ltd acet shell 52e / lot #: 7132998.G2: denmark.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 will be submitted.
Event or Problem Description
It was reported during a clinical study that at the one-year post-op appointment, the patient was experiencing moderate pain, difficulty with ambulation and daily activities.Subsidence of the stem was noted as well.Then, the patient underwent a right hip revision approximately two years post implantation due to pain, difficulty with ambulation and daily activities.The patient was removed from the study and a revision of all the components was completed without any known complications.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; d4; g3; h2; h3; h4; h6.Proposed component code: mechanical (g04)- head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient developed pain, with difficulty ambulating post-op.One year later, the pain persisted so the patient was revised due to stem subsidence and loosening noted.All devices were explanted with unknown products placed.The complaint was confirmed based on the provided medical records.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot 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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: ZB 12/14 COCR HD 36MM X +3.5
• Common Device Name: PROSTHESIS, HIP
• 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 Key: 18758152
• Report Number: 0001822565-2024-00624
• Device Sequence Number: 20410332
• Product Code: LPH
• UDI-Device Identifier: 00889024498891
• UDI-Public: (01)00889024498891(17)311008(10)3089098
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 802203603
• Device Lot Number: 3089098
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 83 KG