MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ossification (1428)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown head lot #: unknown, item #: unknown liner lot #: unknown, item #: unknown cup lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2019 -05140 head, 0001822565 -2019 -04799 liner, 0001822565 -2019 -05136 cup.Customer has indicated that the product will not be returned to zimmer biomet for investigation; due to location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported to 411 that the patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient's liner plans to be revised due to unknown reason.Sales rep was inquiring about id of cup and liner.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records.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.Radiographs identified the following : asymmetric position of the femoral head within the acetabular cup suggesting polyethylene wear was observed.The femoral head appeared to be undersized and there was heterotopic ossification extending from the lateral acetabulum to the greater trochanter with possible bony bridging.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

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

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9483672
• MDR Text Key: 173904502
• Report Number: 0001822565-2019-05138
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other