MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 28MM -6NECK TYPE 1 TAPER COBALT CHROME HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988)

Patient Problem Metal Related Pathology (4530)

Event Date 04/27/2022

Event Type  Injury  

Event Description

It was reported the patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately 23 years post implantation due to metal on metal wear and metallosis found on both acetabular component and femoral stem.Additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Concomitant products: unknown mallory acetabular cup 46mm; unknown mallory acetabular 10 degree liner size 22 for 28mm head; unknown taperloc stem.Report source: foreign country (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01000, 0001825034 - 2022 - 01001, 0001825034 - 2022 - 01003.

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.Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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.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.

• Brand Name: UNKNOWN 28MM -6NECK TYPE 1 TAPER COBALT CHROME HEAD
• 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: 14269963
• MDR Text Key: 290655962
• Report Number: 0001825034-2022-01002
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 60 KG