MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR RED/LAT 17.5X155; PROSTHESIS HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problem Pain (1994)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical device: m2a-magnum pf cup 64odx58id, # item us157864, lot: 792860; m2a-magnum mod hd sz 58mm, # item 157458, lot: 832880; m2a-magnum 52-60mm tpr insrt-6, # item 139264, lot: 348620.Reported event was confirmed by review of op notes provided.Revision op notes dated were reviewed and identified patient was revised due to pain.During the revision, it was identified femoral head could not be disassociated from the stem with noted trunnionnosis.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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 that the patient's right hip was revised approximately 7 years post implantation due to pain, discomfort, soreness, dysfunction, loss of range of motion and elevated metal ions.The surgeon found irritative joint fluid within the capsule when they opened the joint.

• Brand Name: TAPERLOC POR RED/LAT 17.5X155
• 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: 8744445
• MDR Text Key: 149511803
• Report Number: 0001825034-2019-02823
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2009
• Device Model Number: N/A
• Device Catalogue Number: 13-103209
• Device Lot Number: 479640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• 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