MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COCR CABLE SLEEVE 2.0MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 12/03/2007

Event Type  Death  

Manufacturer Narrative

(b)(4).Concomitant medical products: ml-hd mod calc prox 34b part 108112 lot 940540, r/h m/h 13x220 80%(165) distal part 11-108253 lot 232980, 36 mm cocr mod hd std part 11-363662 lot 096120, m/h 3hole rlc shl nrs 58 mm/l25 part 13-104158 lot 081530, arcomxl 36 mm rlc lnr hw sz25 part xl-105915 lot 054370, cocr cable sleeve 2.0 mm part 120005 lot 777870, cocr troch cable 2.0 mm x 750 mm part 120002 lot 857330, cocr troch cable 2.0 mm x 750 mm part 120002 lot 107110.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-06925-1, 0001825034-2018-06942-1, 0001825034-2018-06932-1, 0001825034-2018-06940-1, 0001825034-2018-08983, 0001825034-2018-08985, 0001825034-2018-08986, 0001825034-2018- 08987, 0001825034- 2018-08988, 0001825034-2018-08989, 0001825034-2018-08991, 0001825034-2018-08992.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

It was reported a patient underwent initial right total hip arthroplasty approximately 11 years ago.The patient expired due to gastrointestinal hemorrhage approximately 4 months post implantation.No further information concerning the timeline of events between hip arthroplasty and patient death has been provided.Attempts were made to obtain additional information; however, none is available.

• Brand Name: COCR CABLE SLEEVE 2.0MM
• Type of Device: PROSTHESIS, HIP
• 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: 7885808
• MDR Text Key: 120572860
• Report Number: 0001825034-2018-08984
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK982545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 120005
• Device Lot Number: 107130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 68