MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK D 12/14 NECK TAPER; PROSTHESIS, HIP

Catalog Number	00784804400
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530); Joint Impingement (4834)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02858.D10: cat #: 00875801232 / 32mm i.D.Size kk with constraining ring constrained liner use with 56mm o.D.Size kk shell do not use with skirted heads / lot #: 63830633.Cat #: 00877503202 / biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14 / lot #: 2919486.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 a patient underwent a hip revision approximately five years post implantation due to pain and a dislocation.During the revision, it was noted that the liner and ring were intact and that there was significant metal debris (black tissue) found in the wound site.Upon examination of the anterior neck, it was discovered that this item was grinding on the acetabular cup.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).During the investigation of the reported event, it was determined to be not reportable as this product was not involved in the initial event.The initial report should be voided.
Event or Problem Description
During the investigation of the reported event, it was determined to be not reportable as this product was not involved in the initial event.The initial report should be voided.

• Brand Name: MODULAR NECK D 12/14 NECK TAPER
• 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: 17957839
• Report Number: 0001822565-2023-02859
• Device Sequence Number: 12082817
• Product Code: LPH
• UDI-Device Identifier: 00889024138049
• UDI-Public: (01)00889024138049(17)270930(10)63789786
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K182678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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 Catalogue Number: 00784804400
• Device Lot Number: 63789786
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2017
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 77 KG