MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZCA CUP; COMMON DEVICE NAME

Model Number N/A

Device Problems Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 09/21/2021

Event Type  Injury  

Event Description

It was reported patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately 12 years post implantation due to aseptic loosening.Corrosion was found on the stem explanted stem.Review of x-rays received show asymmetric positioning of the femoral head within the acetabular component consistent with polyethylene wear.Possible radiolucency at the bone cement interface suggest loosening of the acetabular component.Lucency along the tip of the femoral stem with cortical thickening of the lateral cortex of the femoral stem could indicate loosening.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4); concomitant products: 00811400100 60776286 femoral stem 12/14 neck taper standard offset size 1 130 mm stem length; unknown head.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.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: 0001822565 - 2021 - 02855.

Manufacturer Narrative

Reported event was confirmed by review of radiographs received.Review of the available records identified polyethylene wear of the acetabular cup, loosening at the bone cement interface and possible loosening of the tip of the femoral stem.Visual examination of the provided pictures identified multiple spots of black discoloration on the body of the stem.The neck taper does not show any damage.No further evaluation can be made from the provided pictures.Device history record (dhr) 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.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.

• Brand Name: UNKNOWN ZCA CUP
• Type of Device: COMMON DEVICE NAME
• 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: 13443198
• MDR Text Key: 285035868
• Report Number: 0001822565-2022-00332
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/15/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 02/17/2022
• 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