MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BI-METRIC CDH POR N/C 7X114; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Blood Loss (2597); No Code Available (3191)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: 162307 ¿ bi-metric femoral stem ¿ 966440; 11-173660 ¿ m2a modular head ¿ 430130; rd118856 ¿ m2a cup ¿ 330980; 113845 - low profile screw - 426960; 113846 - low profile screw - 255104; 113847 - low profile screw - 297849; 113845- low profile screw - 454210.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location 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: 0001825034 - 2018 - 03392, 0001825034 - 2018 - 03391, 0001825034 - 2019 - 00866, 0001825034 - 2019 - 00869, 0001825034 - 2019 - 00870, 0001825034 - 2019 - 00871.

Event Description

It was reported that patient underwent a second right hip revision approximately 12 years post implantation due to pain, dislocation, metallosis, and painful shortened leg.During the surgery, the femoral stem was noted to have extensive amount of proximal bone loss riding high in the soft tissues.Large collection of serous fluid was found along with loose rim screws.The acetabular cup found within the soft tissues.Extensive metallosis was found around the acetabulum.

Manufacturer Narrative

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

It was reported that during the second revision, the patient experiencing approximately 1000 ml of blood loss and received 225 ml autologous red blood cells from cell saver reinfused.Attempts have been made and no further information has been provided.

Event Description

No additional information to report at this time.

Manufacturer Narrative

Reported event was confirmed by review of operative notes.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.Contributing factors are degenerative joint disease secondary to childhood hip disease.Patient has significant limitation of motion of her right hip and severe pain attributed to history of multiple surgeries on the right hip as a child.Poor bone quality and patient anatomy with extensive difficulty placing components in initial surgery.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: BI-METRIC CDH POR N/C 7X114
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8373353
• MDR Text Key: 137243564
• Report Number: 0001825034-2019-00863
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 162307
• Device Lot Number: 966440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 03/12/2019; 07/17/2019
• Supplement Dates FDA Received: 03/12/2019; 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention