MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CERCLAGE CABLE; CERCLAGE, FIXATION

Catalog Number 00223200228

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdrs were submitted for this event.Please see associated report(s): 0002648920-2017-00446, 0001822565-2017-04799, 0002648920-2017-00454, 0001822565-2017-04947.Concomitant medical products: versys femoral head/ pn 00801803602/ ln 63177082, versys femoral stem/ pn 00784101500/ ln 63095665, trilogy acetabular liner/ pn 00630505636/ ln 63175336 , shell porous with cluster holes 56 mm o.D.00620005622/ln 63043707.Reported event was unable to be confirmed due to limited information received from the customer.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.Not returned to manufacturer.

Event Description

It was reported that patient had a hip revision approximately 16 months post implantation due to pain, loosening of femoral stem and acetabular cup, infection, and dislocation.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: CERCLAGE CABLE
• Type of Device: CERCLAGE, FIXATION
• 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: 7288040
• MDR Text Key: 100643731
• Report Number: 0001822565-2018-01070
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 00223200228
• Device Lot Number: 62361338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 135