MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS 5CM DIAPHYSEAL SEGMENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00547.
Event or Problem Description
It was reported the patient underwent a right total knee procedure.Approximately 2 years later, the patient was revised due to a fractured oss diaphyseal stem adapter.The surgical technique was not utilized as one of the taper junctions was cold welded together and surgeon had to cut off the broken component in-situ.There was a 1 hour delay in surgery.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures found the adapter has fractured and the taper remains lodged in the diaphyseal segment and appears to be cut by the surgeon for removal.The device was not returned for evaluation.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review found during the revision procedure the surgeon was unable to remove the broken segment from the intact femoral stem.This required a metal cutting bur to cut through the broken segment to remove it from the morse taper/trunnion of the intact stem.This took approximately 1.5 hours with multiple metal cutting burs.Once removed a new diaphyseal segment was placed onto the well-cemented femoral stem.No further complications were noted.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 right knee procedure.Subsequently, the patient was revised two years later due to a fractured oss diaphyseal stem adapter.The oss diaphyseal stem adapter fractured inside of the oss diaphyseal segment.The surgical technique was not utilized as the surgeon was unable to remove the broken segment from the intact femoral stem as they were cold welded together.This required a metal cutting bur to cut through to remove it from the morse tape / trunnion of the intact femoral stem.This resulted in a surgical delay that took approximately an hour and a half with multiple metal cutting burs.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OSS 5CM DIAPHYSEAL SEGMENT
• Common Device Name: PROSTHESIS, KNEE
• 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: 11379515
• Report Number: 0001825034-2021-00565
• Device Sequence Number: 17089246
• Product Code: JDI
• UDI-Device Identifier: 00880304239869
• UDI-Public: (01)00880304239869(17)280329(10)925260
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K123501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 150465
• Device Lot Number: 925260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/20/2021; 06/23/2021; 05/31/2023
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/01/2021; 06/24/2021; 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2018
• 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: Unknown
• 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: Hospitalization; Required Intervention
• Patient Sex: Male