MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO 7 DEG LCK COLLAR; 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 nl 1 cm diasl cnctr, catalog#: cp260605, lot#: 236860.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
Upon reassessment of the reported event it was determined that the device did not contributed to the reported event.The initial report submitted needs to be voided.
Additional Manufacturer Narrative
Upon reassessment of the reported event it was determined that the device did not contributed to the reported event.The initial report submitted needs to be voided.

• Brand Name: MOD ARTHRO 7 DEG LCK COLLAR
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9580992
• Report Number: 0001825034-2020-00232
• Device Sequence Number: 10877338
• Product Code: HSB
• UDI-Device Identifier: 00880304082991
• UDI-Public: (01)00880304082991(17)270928(10)968130
• 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: CP260602
• Device Lot Number: 968130
• Was Device Available for Evaluation?: No
• 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