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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown stem unknown.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02055.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 or Problem Description
It was reported the patient underwent a revision of a right total hip for a replacement head and scrum revision.The patient was revised due to pain post fracture and plating.The patient had extra bone and the revision was performed to help reduce the pain the patient was experiencing.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number.(b)(4) winterthur.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
Upon receipt of additional information, it was confirmed that the femoral head was exchanged during this reoperation to provide better access to the joint space.Therefore, the head served its intended purpose.The product is no longer determined to be part of the reported event and is no longer reportable.
Event or Problem Description
It was reported the patient underwent a revision of a right total hip.The patient was revised due to pain post fracture and plating.The patient had extra bone and the revision was performed to help reduce the pain the patient was experiencing.The femoral head was removed and replaced.

• Brand Name: ZB 12/14 COCR HD 36MM X -3.5
• Common Device Name: PROTHESIS, 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: 17434802
• Report Number: 0001822565-2023-02015
• Device Sequence Number: 12462260
• Product Code: LPH
• UDI-Device Identifier: 00889024498877
• UDI-Public: (01)00889024498877(17)290531(10)2996580
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 08/11/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 802203601
• Device Lot Number: 2996580
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 08/09/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/09/2023; 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown