MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA.; TRAUMA IMPLANT

Catalog Number 00223200418

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/20/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi# (b)(4).Device available for evaluation: 00783301100 femoral stem cemented ld/fx collared 12/14 neck taper size 11 61380176, 00801803602 femoral head sterile product do not resterilize 12/14 taper 61261983, 00620205422 shell porous with cluster holes 54 mm 61143595, 00630505036 liner standard 3.5 mm offset 36 mm i.D.61273251.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device location unknown.

Event Description

It was reported that patient underwent left hip revision where a cerclage cable was placed.Subsequently, the patient was revised due to unknown reasons.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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: CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA.
• Type of Device: TRAUMA IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9527756
• MDR Text Key: 173176706
• Report Number: 0001822565-2019-05470
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• PMA/PMN Number: K151907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: 00223200418
• Device Lot Number: 60884475
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention