MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER SIZE 12.5 EXTENDED OFFSET; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem No Information (3190)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part: 00801803202, lot: 64119270; part: 00875305401, lot: 63941150; part: 00875201132, lot: 63938865.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00512.

Event Description

It was reported that the patient underwent revision surgery due to metal ions.The cobalt chrome head was removed.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).G2: report source: canada 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.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.

Manufacturer Narrative

The stem was not returned as it remains implanted.Review of complaint history identified additional similar complaints for the reported items and no additional complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review (reference (b)(4)) in order to identify potential adverse trends.Root cause unchanged.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: FEMORAL STEM 12/14 NECK TAPER SIZE 12.5 EXTENDED OFFSET
• 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: 10968550
• MDR Text Key: 220214229
• Report Number: 0001822565-2020-04037
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024131880
• UDI-Public: (01)00889024131880
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2022

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 Model Number: N/A
• Device Catalogue Number: 00771101220
• Device Lot Number: 64037326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 03/25/2021; 01/04/2022
• Supplement Dates FDA Received: 03/25/2021; 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2018
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention