MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO 0 DEG LCK COLLAR; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03698.Concomitant medical products: oss segmental stacking adapter, catalog#: 150483, lot#: 580530; cps lg spdl with pins 800lbf, catalog#: 178358, lot#: 502600; cps anchor plug 14mm, catalog#: 178404, lot#: 213070; cps transverse pin 6pk 32mm, catalog#: 178527, lot#: 134880; cps centering sleeve 18mm, catalog#: 178540, lot#: 131070; cps nut co-cr-mo alloy, catalog#: 178512, lot#: 498690; cps anchor plug 10mm, catalog#: 178400, lot#: 182490; cps sm spdl with pins 800lbf, catalog#: 178355, lot#: 717020; cps/oss 5cm tpr adapt w/oss sc, catalog#: 178711, lot#: 433100; cps nut co-cr-mo alloy, catalog#: 178512, lot#: 222820; cps transverse pin 6pk 32mm, catalog#: 178527, lot#: 742300; cps centering sleeve 15mm, catalog#: 178537, lot#: 935290; cps/oss 5cm tpr adapt w/oss sc, catalog#: 178711, lot#: 250750; mod arthro nl 3cm diasl cnctr, catalog#: cp260607, lot#: 580090; mod arthro nl 3cm diasl cnctr, catalog#: cp260607, lot#: 181570; oss 4cm diaphyseal segment, catalog#: 150482, lot#: 801580.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 Description

It was reported that a patient underwent an initial knee procedure.Subsequently, the patient was revised due to unknown reason.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.No devices or medical records were received.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

No further event information available at the time of this report.

• Brand Name: MOD ARTHRO 0 DEG LCK COLLAR
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8930368
• MDR Text Key: 155502628
• Report Number: 0001825034-2019-03697
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K042049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP260600
• Device Lot Number: 491090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 86