MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS TIBIAL POLY BEARING 12MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately six weeks post implantation due to patella dislocation.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).Medical product: oss 7cm segmental femoral lt item# 150355 lot# 705500; oss cemented im stem 13x150 50 item# 150367 lot# 093480; oss non-mod tib plate long 67 long item# 150420 lot# 781270; oss 7cm diahpyseal segment item# 150466 lot# 754400; oss poly tibial bushing item# 150476 lot# 043830; oss poly femoral bushings item# 150477 lot# 685740; oss poly lock pin item# 150478 lot# 949700; oss axle item# 150480 lot# 949700; oss reinforced yoke item# 150493 lot# 898020.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.
Additional Manufacturer Narrative
It was determined the patient did not have a patella implant and only the articular surface, axle and lock pin were revised.The components that were revised are required to be revised whenever the knee is opened.The initial report should be voided.
Event or Problem Description
It was determined the patient did not have a patella implant and only the articular surface, axle and lock pin were revised.The components that were revised are required to be revised whenever the knee is opened.The initial report should be voided.

• Brand Name: OSS TIBIAL POLY BEARING 12MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13002730
• Report Number: 0001825034-2021-03346
• Device Sequence Number: 4316869
• Product Code: JDI
• UDI-Device Identifier: 00880304239388
• UDI-Public: (01)00880304239388(17)241216(10)050940
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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 Expiration Date: 12/16/2024
• Device Model Number: N/A
• Device Catalogue Number: 150410
• Device Lot Number: 050940
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown