MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO NL 1CM DIASL CNCTR; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00231 and 0001825034-2020-00232.Concomitant medical products: mod arthro 7 deg lck collar, catalog#: cp260602, lot#: 968130.Mod arthro nl 1 cm diasl cnctr, catalog#: cp260605, lot#: 161950.Oss porous im stem 21.5 x 150, catalog#: 150400, lot#: 360910.Oss porous im stem 18.5 x 225, catalog#: 150405, lot#: 898500.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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 that during a revision of a left knee oss system due to a broken junction/connector component, the surgeon stated that the morris taper could not be broken from the femoral stem despite multiple attempts and different instruments.The surgery had to be modified to cut the segments apart, extending surgical time by an hour.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, associated reports: 0001825034-2020-00231 and 0001825034-2020-02071.This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and the returned device.Medical records were provided and reviewed by a healthcare professional.Review found the stem was well fixed in the patient.The surgeon tried to remove the already fractured diaphyseal connector from the stem but couldn¿t and was noted as an intraop complication that delayed the surgery.Visual examination of the returned product found the connector fractured and intentionally cut on the portion that connects to the stem.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

• Brand Name: MOD ARTHRO NL 1CM DIASL CNCTR
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9580989
• Report Number: 0001825034-2020-00231
• Device Sequence Number: 13589857
• Product Code: HSB
• UDI-Device Identifier: 00880304083028
• UDI-Public: (01)00880304083028(17)280325(10)236860
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K042409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP260605
• Device Lot Number: 236860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Patient Weight: 159