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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544)

Event Date 04/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: m2a-magnum mod hd sz 48mm, catalog# 157448, lot# 463020; m2a-magnum 42-50m tpr insrt +3, catalog# 139258, lot# 958730; m2a-magnum pf cup 54odx48id, catalog# us157854, lot# 497650; bi-metric/x por nc 15x155, catalog# x180315, lot# 821410.Reported event was confirmed by review of op notes.Revision op notes indicate that the patient underwent a left tha revision due osteolysis with pain.Turbid synovial fluid, soft tissue metallosis, osteolysis, as well as trochanteric fracture and bone erosion secondary to osteolysis were identified inter-operatively.Device history record 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.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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 by patients legal counsel that the patient's left hip was revised nine years post-implantation due to pain and difficulty walking and osteolysis.

• Brand Name: COCR CABLE/SLEEVE SET 2.0MM
• Type of Device: HIP PROSTHESIS
• 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: 7112931
• MDR Text Key: 94724357
• Report Number: 0001825034-2017-11143
• 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: consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 120010
• Device Lot Number: 512780
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR