MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK SIZE 10 STANDARD OFFSET; PROSTHESIS, HIP

Model Number N/A

Device Problems Degraded (1153); Material Erosion (1214)

Patient Problems Pain (1994); Local Reaction (2035); Metal Related Pathology (4530)

Event Date 01/18/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a left hip procedure.The patient was revised almost ten years later due to elevated ion levels, metallosis, and pain.Head and liner were replaced.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant products: 00801803202 femoral head 12/14 62028853, 00620205022 shell 50 mm 62039610, 00631005032 liner 10 degree 32 mm 62035883.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2022 - 00049.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, g3, h2, h3, h6.H6: component code: mechanical (g04) - stem.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 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.

Event Description

It was reported a patient had an initial left total hip arthroplasty.Subsequently, the patient began to experience progressive trochanteric pain and serum lab work displayed elevated cobalt and chromium levels.The patient underwent a revision where cloudy fluid was encountered, and significant amount of corrosion was found on the trunnion.The head and liner were revised without complication.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: a1, b5, b7, e1, e2, e3, g3, g6, h2.

• Brand Name: FEMORAL STEM 12/14 NECK SIZE 10 STANDARD 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.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 13695054
• MDR Text Key: 289857549
• Report Number: 0001822565-2022-00675
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2024

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: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00771101000
• Device Lot Number: 62014601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 05/05/2022; 04/22/2024
• Supplement Dates FDA Received: 05/10/2022; 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2012
• 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): Required Intervention; Hospitalization
• Patient Sex: Female