MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, ø 40/+7, TAPER 12/14; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Failure of Implant (1924)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10.40mm i.D.Size g high wall liner item#30124007 lot#66152419.Unknown acetabular component.Product has been received by zimmer biomet and 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: medwtach: 0009613350-2023-00640.

Event Description

It was reported that a total hip arthroplasty was performed in (b)(6) of this year and the doctor noticed on x-ray postoperatively that the femoral head was not sitting in the center of the acetabular component.A head and poly exchange was surgically performed and it was found that the polyethylene head was not properly locked into the acetabular component.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Visual examination of the returned product identified the following 2 etchings around the rim of the taper; 1026474 and 40-12/14+7.The outer radius of the head has been scuffed such that dark foreign material has transferred onto the head.The majority of the scuffing falls on 1 side of the head.Scratching was also observed around and inside the taper.A review of the device manufacturing records for item# 00877504004, lot# 3141169 confirmed no abnormalities or deviations.Device is used for treatment.The reported product was reviewed for compatibility with no issues noted.Review of the complaint history for item# 00877504004, lot# 3141169 found no additional related complaints for this item and the reported part and lot combination.Medical records were not provided.With the available information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00640-1.

Event Description

Diligence is complete and additional information on the reported event is unavailable at this time.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, ø 40/+7, TAPER 12/14
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18171827
• MDR Text Key: 328551820
• Report Number: 0009613350-2023-00639
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071535¦K130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877504004
• Device Lot Number: 3141169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male
• Patient Weight: 137 KG