MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM MOD HEAD COCR -3MM NECK; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Nausea (1970); Pain (1994); Dizziness (2194); Ambulation Difficulties (2544); Balance Problems (4401); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 11-104209, lot: 831670, mlry-hd lat por fmrl 9x150mm.Part: 14-103654, lot: 651160, univ 2-hole shl 54mm lnr sz 24.Part: xl-105924, lot: 418200, arcomxl 32mm rlc lnr hw sz24.Part: 103536, lot: 027150, ti low profile screw 6.5x45mm.Report source: foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02726, 0001825034-2021-02761, and 0001825034-2021-02762.

Event Description

It was reported the patient underwent a hip arthroplasty and subsequently 5 years later is experiencing pain, loss of balance, dizziness, elevated metal ions, difficulty in walking and upset stomach due to the deterioration and failure of implant.No revision has been reported at this time.Attempts have been made and no further information has been provided.

Event Description

It was reported the patient underwent a left hip arthroplasty and subsequently 5 years later is experiencing pain, loss of balance, dizziness, elevated metal ions, difficulty in walking and upset stomach due to the deterioration and failure of implant.No revision has been reported at this time.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, b7, g3, h2, h3, h6.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.

• Brand Name: 32MM MOD HEAD COCR -3MM NECK
• 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: 12543510
• MDR Text Key: 273675739
• Report Number: 0001825034-2021-02756
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00880304256637
• UDI-Public: (01)00880304256637(17)250910(10)324300
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K942479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• 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: 163668
• Device Lot Number: 324300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2015
• 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): Other
• Patient Sex: Male