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

Model Number N/A

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Synovitis (2094)

Event Date 07/01/2019

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 remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Dob ¿ unknown day and month in (b)(6).Concomitant medical products: part: 010000664, g7 pps ltd acet shell 54f, lot: 3058955, part: 010000850, e1 std poly liner f32, lot: 3081924, part: 163668, 32mm mod head cocr -3mm neck, lot: 00j3082022, part: 103201, taperloc por fmrl 6.0x132, lot: 2447794.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: cup: 0001825034-2019-02573, liner: 0001825034-2019-02575, head: this mfr report, stem: 0001825034-2019-02603.

Event Description

It was reported that a patient underwent an initial total hip arthroplasty.Subsequently, approximately seven years later, the patient is indicated for revision due to recurrent cysts in the hip.However, no revision procedure has been reported to date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that a patient underwent an initial total hip arthroplasty.Subsequently, approximately seven years later, the patient was revised due to recurrent cysts in the hip.During surgery, synovitis, cup and liner wear, and in-vivo corrosion of the head and neck were noted.Attempts have been made and no further information has been provided.

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 confirmed by review of medical records.Review of the medical records identified that the patient was revised due to a cyst and trunnionosis.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 32MM MODULAR HEAD COCR -3MM NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8704426
• MDR Text Key: 148185434
• Report Number: 0001825034-2019-02576
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K974558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2019

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 Model Number: N/A
• Device Catalogue Number: 163668
• Device Lot Number: J3082022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 07/02/2019; 09/30/2019
• Supplement Dates FDA Received: 07/30/2019; 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 62